Vascular closure devices and methods of use

ABSTRACT

A closure device system for sealing a percutaneous puncture in a vessel wall can comprise a toggle configured to engage an interior surface of the vessel wall, a plug configured to engage an exterior surface of the vessel wall, and a suture that extends through the plug and through the toggle along at least a first direction so as to couple the toggle to the plug. The system can further comprise a tube that extends through the plug and through the toggle along the first direction such that a distal end of the tube is disposed distally to the toggle. The tube can define a guidewire lumen that extends therethrough along the first direction. And the guidewire lumen can be configured to receive a guidewire that protrudes from the vessel wall such that the plug, toggle, and tube are slidable along the guidewire toward the vessel wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/835,524, filed Mar. 31, 2020, which is a divisional application ofU.S. application Ser. No. 14/777,090, now issued as U.S. Pat. No.10,639,019, filed Sep. 15, 2015, which is a National Stage Applicationfiled under 35 U.S.C. 371 of International Application No.PCT/US2014/022416, filed Mar. 10, 2014, which claims priority to U.S.Provisional Application No. 61/794,776, filed Mar. 15, 2013, thecontents of which are hereby incorporated by reference as set forth intheir entirety herein.

BACKGROUND

U.S. Pat. No. 5,282,827 (hereinafter, the '827 patent), entitledHemostatic Puncture Closure System and Method of Use, discloses systemsfor sealing a percutaneous incision or puncture in a blood vessel. Thesystems of the '827 patent comprise a closure device, an introducer, anda deployment instrument including a carrier for the closure device. Theclosure device has three basic components, namely, a sealing member, anintra-arterial anchor, and a positioning member.

The sealing member is in the form of an elongate, rod-like plug, e.g., acompressed hemostatic, resorbable collagen sponge or foam. This plugmember is arranged for sealing the puncture. The anchor is an elongate,stiff, low-profile member which is arranged to be seated inside theartery against the artery wall contiguous with the puncture. The anchoris molded of non-hemostatic resorbable polymer similar to conventionalresorbable sutures.

The positioning member comprises a filament, e.g., a resorbable suture.The filament connects the anchor and the collagen plug (sealing member)in a pulley-like arrangement, and includes a portion extending outsidethe patient's body. The outwardly located filament portion is arrangedto be pulled, i.e., tension applied thereto, after the anchor is locatedwithin the interior of the artery and in engagement with the inner wallof the artery contiguous with the incision or puncture. The pulling onthe filament causes its pulley arrangement to move the plug in thepuncture tract toward the anchor. A tamper forming a portion of thedeployment instrument is slid down the filament while the filament ismaintained in tension to gently tamp the plug in the puncture tract tocause the plug to deform so that its diameter increases. Tension ismaintained on the filament by use of an externally located spring duringthe tamping procedure.

The expansion of the plug within the tract is enhanced by the fact thatit is formed of a compressed collagen so that it expands in the presenceof blood within the puncture tract. The expansion of the plug within thepuncture tract serves to hold it in place. Moreover, the closure devicequickly becomes locked in place through the clotting of the hemostaticcollagen plug within the puncture tract. The spring serves to hold theplug in its deformed state until such time that the plug is locked inplace by the hemostatic clotting action. Once this has occurred, so thatthe plug is effectively locked within the puncture tract, the externallylocated spring can be removed. This typically occurs after approximately30 minutes. After the spring is removed, the filament is severed at thetop of the tamper. The tamper is then removed and the remaining portionof the filament is cut subcutaneously prior to the discharge of thepatient. The portion of the filament connecting the anchor to the plugremains in tension, thereby holding the closure device permanently inplace until it is eventually absorbed by the patient's body.

U.S. Pat. No. 5,662,681 (hereinafter, the '681 patent), entitledSelf-locking Closure for Sealing Percutaneous Punctures, also teachessystems for sealing a percutaneous incision or puncture in a bloodvessel.

SUMMARY

In accordance with an embodiment, a closure device system for sealing apercutaneous puncture in a vessel wall can comprise a toggle configuredto engage an interior surface of the vessel wall, a plug configured toengage an exterior surface of the vessel wall, and a suture that extendsthrough the plug and through the toggle along at least a first directionso as to couple the toggle to the plug such that the plug is proximal tothe toggle. The system can further comprise a tube that extends throughthe plug and through the toggle along the first direction such that adistal end of the tube is disposed distally to the toggle. The tube candefine a guidewire lumen that extends therethrough along the firstdirection. And the guidewire lumen can be configured to receive aguidewire that protrudes from the vessel wall such that the plug,toggle, and tube are slidable along the guidewire toward the vesselwall.

In accordance with another embodiment, a closure device system forsealing a percutaneous puncture in a vessel wall can comprise a closuredevice configured to seal the puncture, and a deployment device. Thedeployment device can include a delivery tube that is elongate along afirst direction and is configured to hold the closure device in apre-deployment state, and a guidewire tube that extends through at leasta portion of the closure device within the delivery tube and along thefirst direction such that the guidewire tube moves relative to theclosure device as the closure device is deployed from the delivery tube.The guidewire tube can define a lumen that extends therethrough alongthe first direction and can be configured to (i) receive a guidewirethat protrudes from the vessel wall such that the closure device anddeployment device are together slidable along the guidewire toward thevessel wall.

In accordance with another embodiment, a method of sealing apercutaneous puncture in a body passageway of a living being cancomprise the steps of inserting a guidewire into the body passagewaysuch that the guidewire extends from outside the body passageway,through the puncture, and into the body passageway; inserting theguidewire into a guidewire lumen defined by a guidewire tube of aclosure device system, the closure device system further including atoggle and a plug slidably coupled to the guidewire tube; and moving theclosure device system along the guidewire such that the toggle entersthe body passageway through the puncture.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofan example embodiment of the application, will be better understood whenread in conjunction with the appended drawings, in which there is shownin the drawings example embodiments for the purposes of illustration. Itshould be understood, however, that the application is not limited tothe precise arrangements and systems shown. In the drawings:

FIG. 1 is a diagram showing the clinical setting of a large bore sheathand a guide wire;

FIG. 2A is a diagram depicting a closure device;

FIG. 2B is a cross-sectional view of the closure device of FIG. 2A;

FIG. 3A is a diagram of an exemplary deployment instrument according toan exemplary embodiment;

FIGS. 3B-3F depict additional details of the deployment instrument ofFIG. 3A;

FIG. 3G depicts an exemplary kit according to an exemplary embodiment;

FIG. 4A is a diagram showing how an exemplary closure device is insertedinto the sheath and artery;

FIG. 4B is a diagram showing how an exemplary closure device is insertedinto the sheath and artery;

FIG. 5 is a diagram showing how the sheath and the closure device arepositioned in the large arteriotomy;

FIG. 6 a diagram showing how the toggle is released in preparation fordeployment;

FIGS. 7 and 8A-8B are diagrams showing how the device is deployed toseal the puncture;

FIGS. 9A-9F depict exemplary toggle-guide wire associations;

FIGS. 10A-10C depict exemplary toggle-filament associations;

FIGS. 11A-11C depict exemplary tampers;

FIG. 12A-12B depict exemplary features of a tamper;

FIG. 13 depicts an alternate embodiment of a deployment instrument;

FIG. 14 depicts use of the embodiment of FIG. 13;

FIGS. 15-18 depict features of an exemplary tensioner according to anembodiment;

FIG. 19 is a flowchart of an exemplary method;

FIGS. 20A-20B depict an embodiment utilizing a plurality of plugs;

FIG. 21 depicts an embodiment utilizing a dual-lumen tamper;

FIG. 22-23 depict use of an occlusion balloon to hold a toggle againstan artery wall;

FIGS. 24A-24D depict an alternate embodiment of a toggle;

FIGS. 25A-25C depict an end view of use of a balloon to hold a toggleagainst an artery;

FIGS. 26A-26B depict an alternate embodiment of a toggle;

FIGS. 27A-27D depict an exemplary embodiment of a marker; and

FIGS. 28-30 depict exemplary embodiments of guide wire-plug association.

FIG. 31 depicts an exemplary embodiment of an exchange sheath systemcomprising an accessory sheath and introducer;

FIG. 32 depicts an exemplary embodiment of the delivery system and theassociated accessory sheath;

FIG. 33 depicts an exemplary embodiment of the closure device centeredon a guidewire and its associated delivery system; and

FIG. 34 depicts an exemplary embodiment of the closure device centeredon a guidewire lumen and its associated delivery system.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Some exemplary embodiments are directed towards wound (puncture) closuredevices, systems and methods, and wound (puncture) closure devicedeployment instruments and methods and systems of utilization thereof,associated with closing a relatively large puncture (wound) of anartery, such as by way of example, a femoral artery. Such a largepuncture may exist as a result of a balloon aortic valvuloplasty (BAV)and/or percutaneous aortic valve replacement (PAVR) procedure and/or arelated procedure, which utilize access sheaths from the 18 to 24 Fsize. Hereinafter, these procedures (BAV, PAVR and related procedures)may be referred to as the “referenced vascular treatment procedures.”

An exemplary embodiment of the wound closure system detailed below andsome variations thereof interface with an intravascular guide wire.Accordingly, some exemplary embodiments of use thereof will first bedetailed, followed by a discussion of some specific features to thewound closure system of some exemplary embodiments.

In an exemplary embodiment, a needle cannula usable in a valvuloplastyand/or percutaneous aortic valve replacement procedure is inserted intoan artery. Such a needle may correspond to, by way of example and not byway of limitation, a needle usable in the Seldinger method.

While the needle cannula is in place (extending into the artery), aguide wire is passed through the cannula of the needle a desireddistance into the artery (sufficient for the teachings detailed hereinand/or variations thereof to be practiced, and/or other procedures to bepracticed). In an exemplary embodiment, the guide wire is a so-calledthirty-five thousandths of an inch guide wire. In an exemplaryembodiment, the guide wire is an access guide wire. Once the guide wireis in place, the needle cannula is removed by pulling the needle awayfrom the artery over the guide wire. This leaves the guide wire inplace, with a portion thereof extending the desired distance (orthereabouts) into the artery. This further leaves an incision throughwhich the guide wire extends. As will be detailed below, in an exemplaryembodiment, the guide wire is part of a wound closure device deploymentinstrument, although in other exemplary embodiments, the guide wire is aseparate element.

An introducer sheath, such as a large bore sheath, is passed over theguidewire, through the incision and into the artery, as depicted in FIG.1, where element 10 is a large bore sheath, element 20 is a guide wire,element 1026 is a femoral artery (depicted in cross-sectional view),element 1024 is the puncture in the artery (wound in the artery),element 1025 is the tract leading to the puncture 1024 and element 1028is the skin. By tract it is meant the passageway in the tissue locatedbetween the artery 1026 and the skin 1028 of the being, and which isformed when the artery is punctured percutaneously.

It is noted that the scene depicted in FIG. 1 may be achieved throughother steps than those just depicted by way of example. Any method ormethods that result in the human tissue-medical device interface regimedepicted in FIG. 1 and/or variations thereof, which enable the teachingsherein and/or variations thereof and/or result in the utility of theteachings detailed herein and/or variations thereof, may be used in someembodiments. Indeed, the aforementioned actions may be part of or besubstituted by actions that are part of the referenced vasculartreatment procedures. In any event, after executing such actions, alarge bore sheath 10 remains in a vessel, such as the common femoralartery, as depicted by FIG. 1 and/or a variation thereof.

As can be understood by the diagram of FIG. 1 and attention to thesizing (unless otherwise noted, the drawings herein are drawn to scale),the sheath 10 is relatively large in relation to the inner diameter ofthe vessel (e.g., it has an inner diameter and/or an outer diameter ofabout 0.4, 0.5, 0.6, 0.7 and/or 0.8 or more times the size of the innerdiameter of the artery, as measured on a plane lying normal to thelongitudinal axes of these tubular structures). In this regard, thesheath 10, as it is a large bore sheath, requires a transverse slit(i.e., a slit extending axially) in the artery, which will be relativelylarge (sufficient to receive the sheath 10 therethrough, after theelastic nature of the artery is taken into account).

In an exemplary embodiment, the guidewire 20 is utilized for advancementof a wound closure device deployment instrument through the sheath 10 ingeneral, and movement of a wound closure device in particular along theguide wire. It is noted that some exemplary details of the deploymentinstrument and closure device are provided below. However, in someembodiments, the deployment instrument and/or closure device maycorrespond to the deployment instrument and/or wound closure device ofany of the above referenced applications as modified to interface withthe large bore sheath 10 and/or closure device and/or deploymentinstrument detailed below, wherein the closure device may correspond tothe closure device of any of the above referenced applications asmodified to close such a large opening in the artery (e.g., an openinglarge enough to permit a sheath of 18 F to fit through as depicted inthe figures).

Also shown in FIG. 1 is a PTA balloon 600 inserted proximally or from acontralateral puncture site. This balloon is utilized to block bloodflow proximal to the large bore puncture site (i.e., the site depictedin FIG. 1), and as an entry for contrast dye. Balloon 600 is depicted inan uninflated or semi-inflated state coupled to guidewire 610 or aballoon shaft. In use, inflation fluid is pumped to the balloon, toinflate the balloon 600. It is noted that some embodiments may notinclude the balloon 600/may not utilize the balloon 600.

An exemplary embodiment of a closure device will now be brieflydescribed in the context of the environment of FIG. 1, with someadditional details of the closure device being provided further below.

At some point during the aforementioned procedure, the incision in theartery is utilized for whatever medical purposes associated with theutility of the incision. After such utilization, there is utilitarianvalue in closing the incision. An exemplary embodiment of a closuredevice for closing the incision will now be described in the context ofthe artery 1026.

FIG. 2A depicts an exemplary closure device 85 closing puncture 1024.The closure device 85 includes toggle 30, plug 50 (often referred to inthe art and herein as a sealing member or collagen pad, or simplycollagen), lock 60, and suture (also referred to in the art and hereinas filament) 80, in the fully deployed state with the suture 80 cutbelow the skin level 1028 (the occlusion balloon is depicted in theuninflated/deflated condition. FIG. 2B depicts a cross-sectional view ofthe artery 1026, which details the fit of the toggle 30 to the internaldiameter of the artery, and also depicts the profile of the toggle 30with respect to the longitudinal axis of the artery 1026.

FIGS. 2A and 2B depict by way of example the closure unit 85 (comprisingtoggle 30, collagen 50, lock 60, and suture 80) in the fully deployedstate with the suture 80 cut below the skin level, and the occlusionballoon deflated to re-establish blood flow in the vessel and depict thefit of the toggle 30 to the internal diameter of the vessel,highlighting the low profile of the toggle design, as seen along thelongitudinal axis of the vessel.

In an exemplary embodiment, the closure device 85 can correspond to anyof the above referenced applications as modified to close such a largeopening in the artery (e.g., an opening large enough to permit a sheathof 18 F to fit through as depicted in the figures) and/or to provide analternate access pathway if needed during the procedure in which themethod is executed.

For example, suture (filament) 80 can correspond to filament 34 of U.S.patent application Ser. No. 13/111,653 (hereinafter, the '653application) filed on May 19, 2011, entitled DEPLOYMENT INSTRUMENT FORCLOSURE DEVICE FOR PERCUTANEOUSLY SEALING PUNCTURES, the teachings ofthe '653 application relating to the construction and features of thefilament being incorporated by reference herein for use in an embodimentherein. Lock 60 can correspond to lock 36 of the aforementioned '653application (or any other lock detailed therein and variations thereof),the teachings of the '653 application relating to the construction andfeatures of the lock being incorporated by reference herein for use insome embodiments herein. Collagen 50 can correspond to plug 30 of theaforementioned '653 application, although it is noted that the size ofplug 30 may vary from that disclosed in the '653 application, theteachings of the '653 application relating to the construction andfeatures of the plug 30 being incorporated by reference herein for usein an embodiment herein.

While the toggle 30 is different in size and geometry from thatexplicitly disclosed in the '653 application with respect to that anchor32 detailed therein, in an exemplary embodiment, the toggle 30corresponds to the anchor 32 of the '653 application in a modified formin accordance with the teachings detailed herein and/or variationsthereof, the applicable teachings of the '653 application relating tothe construction and features of the anchor 32 being incorporated byreference herein for use in an embodiment herein.

In an embodiment, the suture 80 is a braided multifilament size 2-0 PLLAsuture. The suture 80 can be made from any synthetic absorbable plasticmaterial that degrades as needed.

The plug 50 comprises a strip of a compressible, resorbable, collagenfoam which includes one or more apertures through which portions of thesuture 80 extend. In an embodiment, the plug 50 is a collagen pad madeof a fibrous collagen mix of insoluble and soluble collagen that iscross linked for strength. In an embodiment, the collagen may beobtained from the connective tissue of animals. The collagen may bepurified from the subdermal layer of cowhide.

The lock 60 comprises a cylindrical piece of resorbable iron and/orstainless steel crimped in a manner to provide a limited amount ofresistance to movement along the suture 80.

An embodiment of the toggle 30 is constructed of a 50/50polylactic-coglycolic acid or other synthetic absorbable polymer thatdegrades in the presence of water into naturally occurring metabolites(e.g., water and CO2). In an embodiment, the toggle 30 is a monolithicstructure formed by a bio-absorbable polymer.

It is noted that the aforementioned closure device 85 is an exemplaryclosure device, and alternate embodiments of such may be used in someembodiments. By way of example only and not by way of limitation, theaforementioned crimped lock may not be present, and instead, thefilament is looped and/or suturing is utilized to hold the relativelocations of the elements of the closure device 85 (e.g., plug 30 andtoggle 30). By way of example and not by way of limitation, the closuredevice may correspond to, scaled for application with large boreapplication or unscaled, that detailed in U.S. Pat. No. 5,282,827(hereinafter, the '827 patent) and/or variations thereof, the contentsof which are incorporated herein by reference in their entirety withrespect to the closure device taught therein. Further by way of exampleand not by way of limitation, the closure device may correspond to,scaled for application with large bore application or unscaled, thatdetailed in U.S. Pat. No. 5,662,681 (hereinafter, the '681 patent)and/or variations thereof, the contents of which are incorporated hereinby reference in their entirety with respect to the closure device taughttherein. Any device, system and/or method of closing the puncture thatutilizes a component that fits into the artery to provide a reactionelement (e.g., toggle 30) against a force applied thereto associatedwith closing the puncture and/or any device, system and/or method ofclosing the puncture that utilizes a plug (e.g., collagen plug 50) maybe used in some embodiments. In some other embodiments, any device,system and/or method of closing the puncture may be utilized.

An exemplary puncture (wound) of which the teachings detailed hereinand/or variations thereof can be utilized to close or otherwise beassociated with is a puncture in an artery having a diameter (inner orouter) of about 10 mm, although such teachings can also be applicable tosuch having a diameter (inner or outer) of about 5, 6, 7, 8, 9, 10, 11,12 and/or about 13 mm or more, or any value in between these valuesand/or any ranges encompassing some or all of these values (includingranges being bounded by the in between values). In an exemplaryembodiment, the puncture extends over an arc, transverse to alongitudinal axis of the artery (about the circumference normal to thelongitudinal axis) of about 90 degrees, although in some embodiments,the arc extends 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70,75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145,150, 155, 160, 165, 170, 175 and/or about 180 degrees, or any value inbetween these values and/or any ranges encompassing some or all of thesevalues (including ranges being bounded by the in between values). By wayof example, the puncture may extend along an arc having a length of 8mm, although in some embodiments, the length is about 3, 4, 5, 6, 7, 8,9, 10, 11, 12, 13, 14 and/or about 15 mm or any value in between thesevalues and/or any ranges encompassing to some or all of these values(including ranges being bounded by the in between values).

As noted above, some additional exemplary features of the componentsthat make up the closure device 85 are further detailed herein. Prior tothat, however, a brief discussion of an exemplary deployment instrumentis provided (with additional details pertaining to the deploymentinstrument being provided further below) for deploying a closure devicesuch as closure device 85 and/or other equivalents thereof and/orvariations thereof.

FIG. 3A depicts an exemplary deployment instrument 100 according to anexemplary embodiment, configured to deploy the closure device 85. Asdescribed herein, deployment instrument 100 includes a closure device 85and a guide wire 20. However, in other embodiments, the deploymentinstrument may not include one or both of these elements.

Briefly, deployment instrument 100 is configured to be inserted intosheath 10. Deployment instrument 100 includes a release tube 40 and ahandle 110. Release tube 40 is configured to move relative to handle 110and release tube support 42 along longitudinal axis 101 via actuation oflever 90 clockwise or counter-clockwise relative to the handle, asdepicted by arrow 102. That is, movement of lever 90 moves release tube40 (sometimes referred to herein as restraining tube 40) inward/proximalto release the toggle 30.

More particularly, FIG. 3B depicts a cross-sectional view of the distalend of the deployment instrument 100, depicting additional components ofthe deployment instrument 100.

As may be seen, deployment instrument 100 includes a delivery tube 120that is located within release tube 40. The plug 50 of closure device 85is located in the delivery tube 120, with filament 80 extending pastplug 50 to toggle 30. It is noted that plug 50 may partially extendoutside of tube 120. In an exemplary embodiment, delivery tube 120corresponds to a carrier assembly (which can include only the deliverytube or can include additional components). As may be seen, toggle 30 islocated such that it is at least partially located in the release tube40. In some embodiments, it may be fully located in the release tube 40(i.e., no part of the toggle 30 extends past the distal tip of the tube40. Toggle 30 is held in place by filament 80. As will be described inmore detail below, guide wire 20 extends through delivery tube 120 andrelease tube 40, as well as through toggle 30 and/or plug 50. In thisregard, FIG. 3C depicts a top view of the distal end of deploymentinstrument 100, with FIG. 3D depicting a side view thereof forcomparison purposes. As may be clearly seen in FIG. 3C, the guide wire20 extends through toggle 30 (through the longitudinal center of thetoggle 30). In an exemplary embodiment, the association of the guidewire 20 with the toggle 30 as detailed herein and/or variations thereofcan have utility in that such may ensure or otherwise effectively and/orsubstantially increase the statistical probability (at least withrespect to that in the absence of the guide wire association) that thetoggle is at least generally if not substantially or about perfectlycentered relative to the incision in the artery.

In an exemplary embodiment, irrespective of the presence or absence ofthe guide wire 20, the plug 50 is held within delivery tube 120 in amanner that is similar to and/or a manner that is the same as thatassociated with the plug 30 of tubular carrier 102 of the '653application, the teachings thereof relating to such being incorporatedby reference herein for use in an embodiment herein.

FIG. 3E depicts an end view of the deployment instrument 100 looking atthe distal end thereof.

In operation, movement of lever 90 on the delivery handle 110 of thedeployment instrument 100 in the direction of arrow 102 moves therelease tube 40 in the proximal direction to about the location depictedin FIG. 3F (although the tube 40 may be moved to other locations inother embodiments, such as to a more distal location). As may be seen,the toggle 30 is now completely outside the release tube 40 and is thus“released.”

In an exemplary embodiment, the deployment instrument 100 is a fullyintegrated system that includes the deployment device 85 and the guidewire 20. In an exemplary embodiment, it is packaged (in, by way ofexample, a sterilized manner). In an exemplary embodiment, it ispackaged in a hermetically sealed package. The guide wire 20 may bewound in a winding with a relatively large radius to avoid kinking theguide wire. FIG. 3G depicts an exemplary closure device kit 1000,including deployment instrument 100, closure device 85 and guide wire 20sterilized and hermetically sealed in package 900. In an exemplaryembodiment, kit 1000 may further include an insertion sheath 10 inpackage 900 and/or in a separate package attached thereto.

It is noted that in an alternate embodiment, the guide wire 20 is notpart of the kit and/or the delivery instrument 100. Instead, it is aseparate component that is threaded through the toggle 30 and/or theplug 50 after access to the delivery instrument 100 (and thus theclosure device 85) is obtained. Accordingly, an exemplary embodimentincludes a method whereby a user, such as a physician or an operationroom nurse or other professional passes an end of a guide wire through ahole in the toggle 30 or otherwise associates the toggle 30 with theguide wire, followed by deployment of the closure device 85. Theguidewire can also be associated with collagen, tamper, and tensioner.

Use of the deployment instrument 100 will now be detailed with respectto an exemplary deployment method of deploying the closure device 85.

With the sheath 10 in place as seen in FIG. 1, the deployment instrument100 is inserted into a proximal end (not shown) of sheath 10 and movedthrough the sheath 10 until the distal end of the instrument 100 endextends out of the distal end of the sheath 10, approximately as shownin FIGS. 4A-4B. In an exemplary embodiment, the guide wire 20 extendsthrough the deployment instrument 100, and the deployment instrument 100slides along the guide wire 20 (guide wire 20 and sheath 10 aregenerally held stationary, relative to artery 1026, while deploymentinstrument 100 is moved through the sheath 10). In an alternateembodiment, the guide wire 20 moves with the deployment instrument 100,at least to a certain extent.

More particularly, FIGS. 4A-4B depicts the relative locations of toggle30, the end of the delivery tube 120, and the release tube 40 of thedeployment instrument 100 with respect to the distal end of the sheath10. This positioning is achieved by driving the deployment instrument100 through sheath 10, over the guide wire 20 and/or with the guide wire20, until the release tube 40, along with the closure device 85 ingeneral and the toggle 30 in particular, as detailed herein and/orvariations thereof (where toggle 30 and plug 50 and some of filament 80is visible in FIGS. 4A-4B), is positioned as shown. The positioning canbe determined via the use of one or more radiopaque markers 44 and/or 45on the release tube 40. The user, utilizing fluoroscopic methods, candetermine the position of radiopaque marker 45, and thus the releasetube 40, relative to the end of the sheath 10. In an exemplaryembodiment, the user stops driving the deployment instrument 100 intothe sheath 10 upon the marker 45 emerging from the sheath 10 (imagedusing fluoroscopic methods). It is noted that other devices, systemsand/or methods may be utilized to determine or otherwise estimate theposition of the end of the release tube 40 relative to the insertionsheath 10. For example, a channel which permits blood to followthrough/along the instrument 100 to a location that is visible by theuser upon the instrument 100 being so positioned may be used in someembodiments. An exemplary embodiment utilizes some and/or all of theteachings associated with determining or otherwise positioningintroducer sheath 28 and/or device 28 of U.S. Pat. No. 5,282,827, thecontents of which associated with such teachings are incorporated hereinby reference for use in some embodiments. Any device, system and/ormethod that will enable the position of the instrument 100 to bedetermined or otherwise estimated may be used in some embodiments. In analternate embodiment, the sheath 10 is sized and dimensioned and/or thedelivery instrument 100 is sized and dimensioned such that movement ofthe deployment instrument 100 through the sheath 10 stops at a certainpoint (e.g., a wall of the deployment instrument 10 abuts the sheath 10)such that the distal end of the deployment instrument 10 extends adistance past the distal end of the sheath 10 a distance havingutilitarian value.

As may be seen in FIGS. 4A-4B, the toggle 30, which in this exemplaryembodiment, is smoothly shaped, is partially covered by the release tube40 upon its emergence from the sheath 10. Because it is exposed, thesmoothness has utility in that it can permit relatively smooth entryinto the artery and can allow for rearward movement of the closuredevice within the artery without risk of the toggle 30 catching on anyplaque or other obstruction. Given the anatomical nature of the accesssite and puncture, the release tube 40 (and the delivery tube 100,sheath 10 and guidewire 20 will be slightly curved as may be seen inFIG. 5. This curvature provides a biasing force on the toggle 30 for therelease actions.

Upon positioning of the deployment instrument 100 at the desiredposition relative to the distal end of the sheath 10 (i.e., at theposition depicted in FIGS. 4A-4B), the lever 90 is rotated relative tothe rest of the instrument 100 in a direction and by a sufficient amountto retract the release tube 40 a utilitarian distance relative todelivery tube 120, thereby entirely exposing the toggle 30. FIG. 5depicts such an exemplary retraction. As may be seen, guide wire 20extends through toggle 30 after retraction of the release tube 40 (andmay also extend through the collagen, tamper and tensioner).

Next, sheath 10 is withdrawn from the approximate position depicted inFIG. 5. However, prior to this, balloon 600 optionally can be inflatedas shown in FIG. 5. Because the sheath 10 may exit the puncture 1024when the sheath 10 is withdrawn from the artery, the balloon is inflatedunder a low pressure to block blood flow from a proximal position atleast prior to fully withdrawing the distal end of the sheath 10 fromthe artery (where blood flow flows from left to right with respect tothe frame of reference of FIG. 5).

As just noted, the insertion sheath 10 is withdrawn from its previousposition, either partially and/or fully out of the artery 1026. FIG. 6depicts withdrawal of the insertion sheath 10. While the sheath 10 iswithdrawn, the relative position of the deployment instrument 100relative to the artery can change, either by the same amount or by alesser or greater amount, although in other embodiments, its locationrelative to the artery may remain the same. Any movement or lack thereofof the instrument 100 relative to the artery may exist in someembodiments providing that it does not negate the utilitarian value ofthe embodiment. Some such movement may be seen by comparing FIG. 6 toFIG. 5. In this regard, FIG. 6 depicts the deployment instrument 100 ingeneral, and the closure device 85 carried thereby, in a positionrelative to the puncture 1024 having utilitarian value. (ok, but sowhat?)

It is noted that in an exemplary embodiment, plug 50 can be withdrawnfrom tube 120 without contacting the sheath 10 and/or at least withoutcontacting the interior of the sheath 10. This may, in some embodiments,eliminate the possibility that the plug 30 might become stuck in thesheath 10—during the deployment procedure as it expands once leaving thetube 120.

In an exemplary embodiment, a contrast agent is injected distal to theballoon 600. Contrast agent can indicate any leakage at the puncturesite and can additionally provide for an outline of the toggle 30 usingfluoroscopic methods (The balloon shaft may also be a shaft, and shouldbe coming in from the left, with the wire extending right, and a shaftoutlet on the right of the balloon).

The sheath 10 and/or the tube 40, are retracted (moved in the directionthat would withdraw them from the patient). The marker is aligned beforerelease as is shown in FIG. 6.

Still referring to FIG. 6, FIG. 6 depicts how the toggle 30 will bereleased from the biased state with retraction of the release tube 40.The release orients the toggle 30 parallel to the vessel axis. Releaseis confirmed by the alignment of the distal radiopaque marker 44 withthe end of the sheath 10 and/or markings on the handle (not shown). Notethat vessel occlusion is maintained during this action, and an outlineof the toggle will be visible to the user on the fluoroscope (as will bedetailed below, the toggle 30 may include material that is readilyapparent through fluoroscopy. Note further that, in an exemplaryembodiment, the contact of the most distal portion of the toggle 30 withthe artery wall forces the toggle 30 to rotate clockwise upon sufficientmovement of the release tube 40, thus aligning the toggle 30 in a mannerthat will statistically improve the chances that the toggle 30 will besufficiently aligned so as to statistically reduce the likelihood (atleast in comparison to the absence of such alignment), if notsubstantially eliminate or completely eliminate the likelihood that itwill be pulled out of the artery during subsequent actions. It is notedthat in some embodiments, radiopaque marker(s) may be located on thesheath 10, such as, by way of example, at the distal end I tip of thesheath 10. Such may be used, in some exemplary embodiments, to determinethe position of the sheath 10. For example, a sheath marker may beutilized to determine the position/estimate the position of the distalend of the sheath relative to the puncture. Such may have utility indetermining whether or not to further retract the sheath 10 from theartery based on the location of the marker. Still further by example,such may be used to determine the location of certain components of thedeployment instrument 100 (e.g., the release tube 40 and/or thedeployment tube 120, such as, by way of example, based on radiopaquemarkers thereon, etc.), relative to the sheath 10.

Next, the delivery instrument 100 is moved proximally such that thedistal tip thereof is moved from the location depicted in FIG. 6 to atleast about the location depicted in the functional schematic of FIG. 7(with sheath 10 not shown for clarity). This results in plug 50 beingcompletely withdrawn from the artery and toggle 30 being drawn closer tothe puncture 1024 and/or substantially or completely against thepuncture 1024. Guide wire 20 may move along with delivery instrument 100partially and/or fully or may remain stationary while the deliveryinstrument 100 is moved to the location of FIG. 7 and locationsthereabouts. Continued movement of the delivery instrument 100 away fromthe puncture, to a location such as that depicted by way of example inFIG. 8A, pulls toggle 30 closer to the puncture and/or completelyagainst the puncture, and also pulls plug 50 out of the delivery tube120 and, as a result of a pulley action/synching action/lassoing actionbetween the filament 80, the toggle 30 and the plug 50, the plug ispulled towards the toggle 30 and thus the puncture 1024 (in someembodiments such that it contacts the artery wall), with guide wire 20having the movements or lack of movements detailed above. Below, anexemplary device that has utilitarian value in moving the plug 50relative to the toggle 30 is described.

Next, the delivery instrument 100 is moved further away from thepuncture to expose some additional components therein, such as, forexample, a tamper, the lock if not already exposed, and additionalfilament 80 (by exposed, it is meant that the delivery tube 120 (orother component of the delivery instrument 100) is pulled past thesecomponents such that the components emerge from the distal end of thetube 120 (or other component that carries these components)). It isnoted that such exposure may be achieved by pulling the handle 110 ofthe delivery instrument 100, which results in pulling of the deliverytube 120 (and the release tube 40), and other components.

FIG. 8B depicts an exemplary result of such movement of deliveryinstrument 10, where tamper 70 has been exposed from the delivery tube100 (not shown in FIG. 8B, as it is exemplary moved out of the fieldrepresented by FIG. 8B). It is noted that the procedure for exposing thetamper 70 and the tamper 70 itself may correspond to the teachings ofsuch exposure and the tamper detailed in the '827 patent, the '681patent and/or the '653 application, the contents of which related tosuch exposure and the tamper being incorporated by reference herein foruse in some embodiments (although it is noted that below, an alternatetamper and an alternate method of exposure and an alternate device forachieving such exposure is detailed).

More particularly, FIG. 8A represents by way of example how retractingthe sheath 10 and deployment instrument 100 can position the toggle 30to cover the interior of the puncture. FIG. 8B represents how furtherretraction of the deployment instrument 100 will deploy the contents ofthe delivery tube 100, namely the collagen 50, lock 60, and tamper tube70, which will allow the user to compress the collagen 50 in place anddeploy the lock 60 (in embodiments that utilize such a lock). In anexemplary embodiment, these components correspond to those disclosed inthe '827 patent, the '681 patent and/or the '653 application, andvariations thereof, as might be scaled for use to procedures disclosedherein. Moreover, the steps of achieving the results depicted in thesefigures may include some and or all of the method steps disclosed in anyof the '827 patent, the '681 patent and/or the '653. As noted above andis further detailed below, toggle 30 position can be confirmedfluoroscopically.

After utilitarian placement of the plug 50 relative to the toggle 30and/or puncture 1024, the plug 50 is locked in place by tamping lock 60with tamper 70 in the distal direction (as represented by arrow 17) asdescribed by way of example in the '653 application. Again, an exemplarydevice that has utilitarian value in tamping lock 60 is described below.

It is noted that in an exemplary embodiment, some or all of the featuresassociated with the methods of delivering the closure device 85(including securing the closure device in place) can correspond to thosevariously taught in the '681 patent, the '827 patent and/or the '653application as implemented utilizing the teachings detailed herein ingeneral and/or the teachings applicable to the delivery instrument 100and sheath 10 in particular, the applicable teachings of those patentsand applications being incorporated by reference herein for use in someembodiments. By way of example, the teachings of the '653 applicationassociated with pulling the plug towards the toggle prior to locking theplug in place may be used in some embodiments.

As detailed above, an exemplary embodiment utilizes a toggle thatmaintains an association with a guide wire. Some exemplary associationswill now be described.

FIG. 9A depicts an exemplary embodiment of a toggle 30A, which can be insome embodiments a large bore toggle, usable in at least someembodiments herein and methods herein. As may be seen, toggle 30Aincludes two holes 31 through which filament 80 may extend, as describedin greater detail below. (Additional features of the structuralarrangement of the toggle are also described below.) Toggle 30A may beutilized in an embodiment where there is no association between thetoggle and the guide wire.

In an exemplary embodiment, toggle 30A and/or the other toggles detailedherein and/or variations thereof are configured to utilitarianly fit toa 10 mm diameter (interior) artery. The toggle 30A has a curved profile,as may be seen in FIG. 9A, which depicts both a top view and a side viewof the toggle 30A. In an exemplary embodiment, the top profile of thetoggle 30A has a generally circular profile having a radius of RI, whichcan be about 5 mm, in an unrestrained configuration, although in someembodiments, the profile may be a radius of about 4 mm, 5 mm, 6 mm, 7mm, 8 mm, 9 mm, 10 mm, 11 mm and/or about 12 mm, or any value in betweenthese values and/or any ranges encompassing some or all of these values(including ranges being bounded by the in between values). It is notedthat in an exemplary embodiment, the aforementioned radii encompass aprofile that is not exactly circular, but instead is elliptical (hencethe use of the term “about”, which, as used herein with respect to anyteaching herein, unless otherwise noted, does not exclude exact valuesand the use of about also includes embodiments not so qualified (i.e.,includes exact numbers, tolerance as would be understood in the art). Inan exemplary embodiment, the toggle has an unrestrained width WI ofabout 6 mm, although in some embodiments, the width WI may be about 2mm, 3, 4, 5, 6, 7, 8, 9 and/or about 10 mm, or any value in betweenthese values and/or any ranges encompassing some or all of these values(including ranges being bounded by the in between values).

In an exemplary embodiment, the radius RI and/or the width WI and/orother pertinent dimensions are such that when applied to a given artery,the wing tips 37A and 37B, as opposed to the longitudinal tips 38A and38B, which run parallel to the longitudinal axis of the artery) contactthe artery wall prior to the center 39 of the toggle 30A. In anexemplary embodiment, the toggle 30A is made of elastomeric materialand/or is of a material such that, when sized and dimensioned for use,allows the toggle 30A to flex (elastically and/or plastically) such thatthe radius RI and/or width WI decreases slightly (to about the interiordiameter of the artery—with or without expansion of the artery (in somecases, the artery is about a zero elasticity tissue, such as may be thecase for statistically very elderly patients for a population in theUnited States of America or Europe)) to conform to or about conform tothe interior diameter, upon tensioning of the filament as detailedherein and/or variations thereof. In this regard, the upper surface maybe characterized as being slightly less curved and/or slightly flatterthan the interior surface of the artery (as taken on a plane normal tothe longitudinal axis of the toggle and the artery, which in someembodiments, will be parallel or substantially parallel and/oreffectively parallel during application).

In an exemplary embodiment, the longitudinal distance of the toggle 30A(tip 38A to tip 38B) is about 16 mm, although in some embodiments, thisdistance may be about 6 mm, 7, 8, 9 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26 and/or about 27 mm, or any value inbetween these values and/or any ranges encompassing some or all of thesevalues (including ranges being bounded by the in between values).

FIG. 9B depicts an alternate toggle, toggle 30B, which includes a hole32, as may be seen, which accommodates the guide wire 20. Particularly,guide wire 20 extends through hold 32, and hole 32 permits guide wire 20to slide or otherwise move therethrough. As may be seen, Hole 32 islocated at about the lateral center of the toggle 30B (lateral centerbeing on the lateral axis 301B, as may be seen) as well as or in thealternative, centered along the axis of the suture holes 31, which maybe slightly offset from the lateral axis 301B.

In an exemplary embodiment, the location of hole 32 is different thanthat depicted in FIG. 9B. For example, FIG. 9C depicts hole 32 locatedin the longitudinal center of the toggle 30C (longitudinal center beingon the longitudinal axis 301C, as may be seen), and/or, the hole 32 islongitudinally in between the holes 31 in the toggle. Any placement ofhole 32 in the toggle that will enable the teachings detailed hereinand/or variations thereof to be practiced or otherwise to haveutilitarian value may be implemented in some embodiments. Also, in someembodiments, association of the toggle with the guide wire is achievednot by a hole through the toggle, but via a notch on the edge of thetoggle, as may be seen in FIG. 9D, where toggle 30D has a notch 33. Suchan embodiment can further include one or more holes through which theguide wire extends. An exemplary embodiment that achieves associationwith the guide wire and the tamper?? toggle? via a notch that has aC-Shaped cross-section (or other equivalent cross-section that achievesthe following functional result) such that the guide wire is “trapped”or otherwise retained therein. For example, if the C-shaped interior ofthe notch is such that the distance between the ends of the C is lessthan the maximum diameter of the guide wire 20, the guide wire should beretained therein. Alternatively, the notch exists, but the guide wire isnot trapped or otherwise retained in the notch. Any device, system andor method of achieving and/or maintaining an association between theguide wire and the toggle may be practiced in some embodiments detailedherein and/or variations thereof.

In an alternate embodiment, a suture hole may be utilized as a hole toachieve association between the toggle and the guide wire/a hole for theguide wire may be utilized to pass a filament 80 therethrough. FIG. 9Edepicts such an exemplary toggle 30E. Such may be achieved by making asuture hole with a larger diameter than that which is would otherwise bethe case for association with a suture alone.

FIG. 9F depicts an alternate embodiment where two holes 32 are utilizedto respectively associate two guide wires 20 with the toggle 30F.Accordingly, such an exemplary embodiment may utilize two guide wires.In some embodiments, three or more guide wires and a correspondingnumber or different number of association devices (e.g., holes, notches,etc.) are utilized.

FIG. 10A depicts an exemplary filament 80 weave through holes 31 of anexemplary toggle 30F, with element 81 corresponding to, for example,loop 50A and winding 52 as detailed in the '653 application, thecontents of which related to the loop and winding thereof beingincorporated herein by reference in an exemplary embodiment. It is notedthat the exemplary embodiment of FIG. 10A includes a suture hole 31spacing width W2 that is wider than that depicted in the exemplarytoggle of FIG. 9A. In an exemplary embodiment, the holes 31 are about 4mm from one another (W2 equals about 4 mm), although in someembodiments, W2 is about 2 mm, 2.5, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm,5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm and/orabout 10 mm or any value in between these values and/or any rangesencompassing some or all of these values (including ranges being boundedby the in between values). It is noted that the spacing between theholes 31 of the toggle of FIG. 9A correspond to about 1.5 mm. In anexemplary embodiment, the hole spacing is sized so as to providesufficient structure that provides utilitarian value with respect toproviding sufficient material to react against the tension applied tothe filament (e.g., it will not break the toggle during tensioning).

It is noted that the weave depicted in FIG. 10A is applicable to thetoggles detailed above and/or below. In exemplary embodiment, element 81is a collar as detailed in the '653 application. Any device system andor method of achieving the utilitarian value of element 81 (e.g., itsuse as a collar), which can include permitting the loop 82 establishedby filament 80 to reduce in diameter (like a lasso or the like) can beused in some embodiments.

FIG. 10B depicts an alternate embodiment utilizing more than two toggleholes 31. As may be seen, four holes 31 are used, through which filament80 is threaded. Such an exemplary embodiment can have utility byimproving pulley action for compressing the plug 50 (not shown in FIGS.10A and 10B), as compared to that resulting from the configuration ofFIG. 10A and/or FIG. 9A.

FIG. 10C depicts an alternate embodiment including a washer (resorbableand/or nonresorbable washer) 500 interposed as seen in the loop 82formed with toggle 30A (or any other toggles described herein and/orvariations thereof). Such may provide for utilitarian management of thewound/puncture at the access site. In an exemplary embodiment, washer500, upon deployment of the closure device 85, becomes located betweenthe vessel wall and the plug 50 (which is interposed in the loop betweenthe toggle 30A and washer 500, but not shown in FIG. 10C), or,alternatively, proximally of the plug 50. In an exemplary embodiment,the distance between the holes of the washer 500 corresponds to thedistance between the holes of the toggle 30A, although in an alternateembodiment, the holes have a different spacing than that of the toggle.(It is noted that the aforementioned hole spacings for the toggle and/orthe washer are centerline to centerline dimensions.)

In an exemplary embodiment, the holes of the washer are about 4 mm fromone another (W2 equals about 4 mm), although in some embodiments, thedistance is about 1 mm, about 2 mm, 2.5, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mmand/or about 10 mm or any value in between these values and/or anyranges encompassing some or all of these values (including ranges beingbounded by the in between values). It is noted that the spacing betweenthe holes 31 of the toggle of FIG. 9A correspond to about 1.5 mm. In anexemplary embodiment, the hole spacing is sized so as to providesufficient structure that provides utilitarian value with respect toproviding sufficient material to react against the tension applied tothe filament (e.g., it will not break the toggle during tensioning).

It is noted that an exemplary embodiment includes a toggle having threeholes 81 or more holes. In an exemplary embodiment, the three holes areutilized with a threaded double suture. The aforementioned togglevarieties also may have holes through which a guidewire may run.

As noted above, delivery instrument 100 includes a tamper 70 therein.While some embodiments include a tamper and are otherwise configuredaccording to the tamper of the '827 patent, the '681 patent and/or the'653 application, an exemplary embodiment includes a tamper 71 thatprovides association between the tamper and the guide wire 20, as willnow be described.

An exemplary embodiment of tamper 71 is depicted in FIG. 11 and includesa double-lumen. Specifically, tamper 71 includes lumen 80′, throughwhich filament 80 extends, and lumen 20′, through which guide wire 20extends. Lumen 80′ is sized and dimensioned, relative to the guide wire20 and the filament 80, to permit movement of the tamper 71 relative tothe filament 80, and lumen 20′, in some embodiments, is sized anddimensioned to permit movement of the tamper relative to the guide wire20, while in other embodiments, it does not permit movement relativethereto.

FIG. 11B depicts an alternate embodiment of a tamper, tamper 72, whichachieves association with the guide wire via the use of guide wirecarriers 20″, through which guide wire 20 extends, the functionalfeatures of tamper 72 being the same as and/or similar to that of tamper71. FIG. 11C depicts another alternate embodiment of a tamper, tamper73, which includes guide wire slot 20″′, through which guide wire 20extends, and is retained therein (slidably or otherwise) via bridges 21attached to the body of the tamper, the functional features of tamper 73being the same as and/or similar to that of tamper 71. An exemplaryembodiment that achieves association with the guide wire and the tamperdoes not include the bridges 21, while including the slot. The slot mayhave a C-shaped cross-section (or other equivalent cross-section thatachieves the following functional result) such that the guide wire is“trapped” or otherwise retained therein even in the absence of thebridges 21. For example, if the C-shaped interior of the slot is suchthat the distance between the ends of the C is less than the maximumdiameter of the guide wire 20, the guide wire should be retainedtherein. Alternatively, the slot exists, but the guide wire is nottrapped or otherwise retained in the slot. Any device, system and ormethod of achieving and/or maintaining an association between the guidewire and the tamper may be practiced in some embodiments detailed hereinand/or variations thereof. It is noted that the embodiment of FIG. 11Acan have utility in that it provides a level of safeguard against a userinadvertently gripping the guide wire or the like during tamping, wherein an exemplary embodiment, the tamper slides relative to the guidewireduring tamping.

FIG. 12 functionally depicts the environment in which tamper 71 isutilized. More particularly, after the delivery instrument 100 iswithdrawn as detailed above to expose the tamper and the othercomponents, tamper 71 is exposed as depicted in FIG. 12A. In theexemplary embodiment depicted in FIG. 12, guide wire 20 and filament 80extend through respective lumens 20′ and 80′. (FIG. 12B depicts across-section of tamper 71 taken at line A-A of FIG. 12B, where theguide wire 12 and the filament 80 have been removed for clarity.)

In an exemplary embodiment, the tamper 71 (or 72 or 73 or variationsthereof) enables tamping action over/along the guide wire 20 and suture80, running through separate lumens 20′ and 80′ in the double lumentamper, until the tamper 71 contacts the lock 60. Upon contact, the userpushes down (continues to push down) on the lock 60 to compress the plug50 in place/to lock the already compressed plug 50 in place (such as isdone by way of example and not by way of limitation, as detailed in the'827 patent, the '681 patent, the '653 application, at least withrespect to movement along the filament thereof), without affecting theplacement of the guide wire 20. The double lumen tamper 71 enablesutilitarian support of the guide wire 20, as compared to the absence ofthe lumen for the guide wire (or the absence of the alternate componentsto achieve association with the guide wire) during the deployment of thedevice and and/or can statistically improve user experience when tampingas compared to tamping without such an association feature.

FIG. 13 functionally depicts an alternate embodiment of a deliveryinstrument 200. It is noted that some and/or all of the additionalfeatures (e.g., the tensioner apparatus, described below) described withrespect to instrument 200 may be included in instrument 100. It isfurther noted that an exemplary embodiment of deployment instrument 200includes some or all of the features of instrument 100 detailed above.

Briefly, movement of the release tube 40 relative to the delivery tube120 is achieved by applying force to section 214 of the release tube 40in the proximal direction of the deployment instrument 100 (200??), asindicated by arrow 201, while applying a reaction force to the deliverytube 120 at section 212 in the direction of arrow 202. Application ofsufficient force thereto drives the release tube 40 towards the proximalend of the instrument 200, and moves it relative to the deployment tube120, until section 214 abuts section 212 or until the force isreduced/eliminated. In this regard, the exemplary embodiment of FIG. 13is such that there is a slight friction fit between the tubes 40 and120, although in an alternate exemplary embodiment, the fit is a slipfit. Alternatively, or in addition to this, additional components, suchas an O ring or the like, may be interposed between the tubes togenerate a modicum of friction. Any device system and/or method ofmoving the tubes relative to one another may be practiced in someembodiments.

In an exemplary embodiment, aside from the different mechanisms utilizedto move the tubes relative to one another, the functionality of thedeployment instrument 200 corresponds to that of the deploymentinstrument 100, as well as its use.

An exemplary embodiment includes a device, system and/or method ofgauging or controlling the application of tension on filament 80 whiledeploying the closure device 85 described herein. Specifically, theapplication of high tension on filament 80 may result in the togglepulling out. Alternatively, insufficient tension will not compress theplug 50 onto the exterior vessel wall.

Prior to describing an exemplary embodiment of a tensioner assembly ofthe delivery instrument 100, some actions associated with deployment ofthe closure device 85 by the deployment instrument 100 will be brieflydescribed (some of which includes redescription and/or variations of thedescription above) in the context of the function of the tensionerassembly.

As detailed above, movement of the deployment instrument 100 in theproximal direction causes toggle 30 to engage the artery wall. As thetoggle 30 catches/engages, resistance will be felt by the user withincreased movement of the deployment instrument 100 in the proximaldirection.

With increased movement of the deployment instrument 100 away from thepuncture, the plug 50 is deployed into the puncture tract with thetoggle 30 engaging or catching the inner surface of the artery wallcontiguous with the puncture. The instrument 100 is then pulled furtheroutward. Inasmuch as the toggle 30 trapped against the interior of theartery wall, the continued retraction of the deployment instrument 100causes the filament 80 to pull the plug 50 out of the delivery tube 120of the deployment instrument 100 and into the puncture tract. As thedeployment instrument comes out of and/or is moved further away from thepuncture tract, continuous steady resistance will be felt as thetensioner assembly of the deployment instrument controls the force onthe filament 80 during the retraction procedure.

Continued retraction of the instrument 100 brings the tamper 70 out ofthe distal end of the deployment instrument 100 (thus exposing thetamper 70).

The retraction of the deployment instrument 100 carries the plug 50 intoengagement with the exterior of the artery wall immediately adjacent thepuncture. Continued retraction causes the filament 80 to deform the plug50, i.e., cause it to deform radially outward, in an exemplaryembodiment, as detailed by way of example in the '827 patent, the '681patent and/or the '653 application, the contents of which relating tosuch deployment/expansion/positioning of the plug incorporated byreference herein for use in embodiments associated with deployment ofthe closure device 85. In an embodiment, the plug 50 (which may be acollagen pad, as noted above) is forced to fold down after exiting thedelivery tube 120 (in some embodiments, it begins to fold downimmediately upon exiting the delivery tube 120). The existence of bloodwithin the puncture tract can further contribute to the deformation ofthe plug 50, because, in some embodiments, it is collagen foam thatexpands and softens in the presence of blood. The retraction procedurecontinues to pull the deployment instrument 100 up the filament 80 untilthe user stops pulling. At this point the plug 50 should be located inthe puncture tract contiguous with the opening in the artery, and thelock 60 (if utilized) located immediately proximally of the plug.

The plug 50 is now ready to be positioned in the tract. To achieve thatend, the user compacts the plug 50 by gently tensioning the filament by,for example, pulling on the handle 110 of the delivery instrument 100 inthe proximal direction with one hand. This moves loop element 81 downalong the filament as a result of tension on filament. Here, toggle 30acts in an analogous manner to a pulley as described in, for example,the '653 application, the contents of which associated with that pulleyaction being incorporated herein by reference for use in an exemplaryembodiment utilizing such pulley action. This has the effect oftightening the loop 82. As element 81 moves down filament section totighten loop 81, it compacts plug 50. This forces plug 50 to conform tothe artery contiguous with the puncture in the artery.

Next, the tamper 71 is manually slid down the filament 80 by the user'sother hand so that it enters the puncture tract and engages the proximalside of the lock 60, if present. A force is applied to tamper 71sufficient to overcome the resistance to movement of the lock 71relative to the filament, at least if the lock 60 corresponds to thelock of the '653 application. This causes the lock 60 to slide downfilament section until it abuts element 81. An exemplary embodiment ofthe lock 60 is configured, when used in conjunction with filament 80, toprovide a certain amount of resistance to movement along filament 80.This locks element 81 in place, as, for example, taught in the '653application, thus preventing loop 82 from expanding. This feature causesthe plug 50 to be secured in the compact position until hemostasisoccurs (which happens relatively very quickly, thereby locking theclosure device in place). That is, because the plug 50 is compressedbetween the toggle 30 and the lock 60, plug 50 is retained or locked inposition within the puncture tract and cannot move away from the toggle,even before the blood clots in the plug.

In an exemplary instrument the deployment instruments detailed hereinand/or variations thereof include a tensioner assembly. Such a tensionerassembly will be described in terms of deployment instrument 200, butare readily applicable to deployment instrument 100, as will now bedescribed.

FIG. 13 depicts a cross-sectional view of deployment instrument 200,including tensioner assembly 140 in the form of a tensioner cartridge160. Tensioner cartridge 160 configured to gauge I measure and/or tocontrol the forces (e.g., tension in filament 80) resulting fromdeployment of closure device 85. The tensioner cartridge 160 providesthe user with visual and/or tactile and/or auditory feedback duringdeployment. The construction of the tensioning cartridge includes aspring 150 located inside a retractable tube 162 that allows for thepassage of filament 80 therethrough. The cartridge 160 includes aretractable member 170. In an exemplary embodiment, the retractablemember 170 is fixedly attached to the filament 80, such that tension onthe filament 80 imparts a force onto the retractable member 170, andthus spring 150. In an alternate embodiment, the filament 80 is attachedto one or more of the coils of spring 150 (e.g., the most proximalcoil/last coil), such that tension on the filament 80 imparts a forceonto the spring 150. In an alternate embodiment, the retractable member170 may include a soft tensioning member 172 through which the filament80 extends. The tensioner assembly 140 one or more utilitarianfunctions. For example, it controls the force applied to the filament 80(and thus the tension) by holding the filament taut during pull back ofthe instrument 200 (or 100) while providing a system for allowing theuser to guard against the application of too much force. By utilizingthe tensioner assembly 140 as detailed below, a user may apply adequatefilament tension for compressing the plug 50 and/or during tamping thelock 60 or other component.

The tensioner assembly may also provide tactile and/or visual and/orauditory indication for the user to stop pulling back and/or to stopapplying additional (increasing) force to the deployment instrument inthe distal direction when the end of suture length has been reachedthrough change in color, shape, etc., visible on the instrument. In anexemplary embodiment, this can prevent or otherwise enable safeguardingagainst excessive force being applied to the toggle, preventing thetoggle from pulling out of the blood vessel.

During use, application of a force onto deployment instrument 100 thatresults in a first tension on the filament is sufficient to withdraw thecartridge 160 out of the delivery tube 120, exposing the cartridge 160such that the user may handle the cartridge 160 with his or her hand. Inparticular, cartridge 160 is carried within delivery tube 120 such thatthere is a light friction fit between the two components. This may beachieved, by way of example, via, elastomeric O-ring 174, as may beseen. Application of the first tension (by applying a sufficientwithdrawal force on the instrument 200 in the proximal direction) issufficient to overcome the friction forces and pull the cartridge 160out of the tube 120. Alternatively, or in addition to this, a snap fitis utilized to retain the cartridge, and a sufficient force applied tothe instrument resulting in sufficient tension on the filament issufficient to release the snap fit. In yet another alternativeembodiment, a positive retention mechanism, such as an actuatingcylinder or box beam, etc., that extends into the tube 120, and thusblocks the cartridge 160 until it is moved out of the tube 120, or atleast from in front of the cartridge 160, may be utilized to retain andthen release the cartridge. Any device, system and/or method that canprovide the modicum of friction between the cartridge 160 and thedelivery tube 120 and/or that provides the modicum of securement so asto releasably retain the cartridge 160 in the delivery tube 120 until itshould be exposed can be utilized in some embodiments. In this regard,it is noted that the first tension may vary between embodiments. By wayof example, the tension associated with overcoming the friction fitutilizing, for example, the O-ring, may be different from thatassociated with overcoming the snap-fit. Moreover, the tension may bevariable or generally constant. For example, the tension duringwithdrawal of the cartridge 160 from the delivery tube 120 will begenerally constant during the withdrawal process with respect to thefriction fit utilizing the O-ring, whereas the tension may vary duringwithdrawal with respect to the snap-fit or the like. Embodiments wherethe tension is relatively constant, or at least moderately increaseswithin a range that does not result in damage to the artery wall and/ordislodgement of the toggle, can have utility in that this results in atension that generally maintains the toggle in place against thepuncture on the interior of the artery.

With respect to the embodiment of FIG. 13, where the O-ring results in afriction fit between the tube 120 and the cartridge 160, application ofthe first tension results in the ejectment/exposure of the cartridge160. This is schematically represented by way of example in FIG. 14.Upon sufficient exposure of the cartridge 160, the user grips thecartridge 160 with a free hand and gradually or abruptly begins to applyforce to the cartridge in the proximal direction at a level that is inequilibrium, in an exemplary embodiment, to that applied to theinstrument 200, until the cartridge 160 is completely free of thedelivery tube 120, at which point the tension in the filament 80 is aresult of force applied to the cartridge 160 in the proximal direction.

An exemplary embodiment of the present invention includes a deploymentinstrument 100 including an exemplary tensioner assembly 1110 as may beseen conceptually in FIG. 15. In an exemplary embodiment, the tensionerassembly 1110 conceptually corresponds to the cartridge 160 detailedabove, although as will be detailed below, in an exemplary embodiment ofthe cartridge 160, there are different features between the two.

A portion of the procedure involving deployment of the closure device 80in a recipient using the exemplary tensioner assembly 1110 of FIG. 15will now be described. As may be seen in FIGS. 15 and 16, the tensionerassembly 1110 includes a frame 1120 in which a hub assembly 1140 isslidably retained. Frame 1120 includes protrusions 1121 that interactwith O-ring 174. In this regard, frame 1120 corresponds to element 161of FIG. 13. The frame 1120 serves as a handle that the user may graspduring application of the closure device 85 to the recipient. In someembodiments, the handle is provided with knurling or tread grips or thelike to facilitate grasping by the user. The hub assembly 1140 includesa hub 1180 and a tensioner insert 1200 (and silicone tension block 1210,which provides constant friction to the filament as it uncoils). The hubassembly is spring loaded by spring 1220 (which corresponds to spring150 of the device of FIG. 13) in the proximal direction of thedeployment instrument 200. That is, with respect to FIG. 15, the spring1220 forces the hub assembly 1140 upward, relative to the frame 1120.Another way of describing this is that the spring 1220 forces the frame1120 downward, relative to the hub assembly 1140.

It is noted that alternate embodiments include structure that isdifferent from that detailed herein. Indeed, a visual comparison betweenthe embodiment of FIG. 13 and that of FIG. 15 reveals that there aredifferences. It is thus again noted that the structure detailed hereinis exemplary and conceptual and can and/or will vary in implementation.In this regard, while the embodiment of FIG. 15 depicts a hub 1140 thatextends into the interior of spring 1220, the embodiment of FIG. 13. Hub1140 corresponds to retractable member 170 of FIG. 13. However,retractable member 170 does not so extend into the spring 150, as may beseen.

In an exemplary embodiment, the spring 1220 permits the tension onfilament 80 to be controlled I ensures that sufficient tensioning andnot too much tensioning is applied to the filament during deployment ofthe closure device 85, as will now be detailed.

Referring to FIG. 15, the tensioner assembly 1110 includes a filamentrecess between the tensioner insert 1200 and a filament cap 1240 inwhich filament 85 is wound in a coil section 80E, from which thefilament 80 travels to the closure device 85. The end of the filament80E is threaded through a hole 1240A in the filament cap 1240 and istrapped between the filament cap 1240 and a filament lock 1260 to holdthe end of the filament 80 in place. Filament lock 1260 may be held tofilament cap 1240 via a screw fit or a snap fit or through the use of anadhesive or a weld, etc. That said, in an alternate embodiment, thefilament 80 extends completely from one side of the hub 1140 (or theretractable member 170) to the other side thereof, and furtherproximally out of the frame 1120 (or element 161).

As may be seen in FIG. 15, a friction block 1210 is located in a cut-outsection of the tensioner insert 1200. In an exemplary embodiment, thefriction block 1210 is a silicon block that is dimensioned such thatwhen inserted in the hub 1180 along with tensioner insert 1200, acompressive force on filament 80 is applied by the friction block 1210and the hub 1140. In some exemplary embodiments, as will be described ingreater detail below, as the filament 80 (filament from section 80E) isdrawn from the spool of the tensioner assembly 1110, the user feels arelatively constant resistance and/or a relatively consistent resistanceas compared to other deployment instruments 100 (i.e., the resistancefelt with one deployment instrument 100 used during a given procedurewill be about the same as that felt during a prior procedure withanother deployment instrument 100). That is, the friction block 1210 incombination with the tensioner insert 1200 and hub 1140 function tocontrol the force required to at least initially withdraw the filament80 from the spool.

In an exemplary embodiment, friction block 1210 corresponds to softtensioning member 172 detailed above with respect to FIG. 13. As hasbeen noted above, the specific structure of various embodiments canvary, while utilizing the principles detailed herein.

As noted above, a force applied to deployment instrument 200 sufficientto result in a first tension in the filament can result in the cartridge160 (or tensioner assembly 1110) being exposed (withdrawn/released frominside delivery tube 120). As noted above, inasmuch as the toggle 30 istrapped (anchored) against the interior of the artery wall, thecontinued retraction of the deployment instrument 200 causes thefilament 80 to pull the plug 50 out of the deployment tube 120 of thedeployment instrument 200. Also, once the toggle 30 catches on the wallof the artery, the filament 80 (filament from section 80E or otherlocation where the filament is stored) will be drawn from the spool ofthe tensioner assembly 1110. Some resistance will be felt, at least inembodiments utilizing the friction block 1210 (or its correspondingstructure 172) described above (as opposed to other embodiments where nodrag force is applied to the filament as a result of compression of thefilament by the friction block, such as in the case where no frictionblock 1210/structure 172 is used and a bore or other space of thetension insert 1200 through which the filament 80 passes is oversizedrelative to the filament 80). This resistance may require the user toapply about ¾ths of a pound of force to the deployment instrument 200 topull the filament 80 out of/through hub 1180/structure 170. The usercontinues to pull the deployment instrument 200 away from the recipientwith a force sufficient to overcome the friction resulting from thecompressive force applied to the filament 80 by the friction block 1210.At a given distance of the deployment instrument 200 from therecipient/from the puncture, the filament 80 will be completely unwoundfrom the spool (or otherwise withdrawn through structure 172 until stop176 strikes structure 172 in the case of cartridge 160). FIG. 16 depictsthe tensioner assembly 1110 in the state where the filament 80 is about½ way unwound from the spool and FIG. 17 depicts the tensioner assembly1110 in the state where all of the filament 80 has been unwound from thespool. The tension on filament 80 is high enough to unwind the filamentfrom the spool, and potentially compresses spring 1220 by acorresponding amount.

At this point, with increasing force applied to the deploymentinstrument 200, the tension in filament 80 reaches a high enough value(the first amount detailed above) to overcome the friction forcesbetween the O-ring and delivery tube 120, and thus the cartridge 160 (ortensioner assembly 1110) becomes exposed (withdrawn/released from insidedelivery tube 120).

At this point, the user grips the cartridge 160 or frame 1120, andcontinues to withdraw the cartridge 160 or frame 1120 away from therecipient with a steady or increasing force. When the tensioner assembly140 1110 is located a first linear distance from the vessel wall,because the end of the filament 80 (or other part of the filament 80) istrapped between filament cap 1240 and the filament lock 1260 (or element176 abuts structure 172), continued pulling of the tensioner assemblyaway from the recipient (past the first distance), when the user holdsthe frame 1120 (or element 162) causes the filament 80 to become moretensioned because the “unwinding” of the filament 80 from the spool hasstopped (there is no more filament from section 80E to be unwound) andthe end of the filament 80 is held in place as it is attached to thetensioner assembly. Accordingly, this increase in tension as the usermoves the deployment tensioner assembly from the first distance from thevessel wall causes frame 1120 (or element 162) to move relative to hubassembly 1140 and thus causes spring 1220 (or spring 150) to compress orfurther compress. The force compressing the spring is substantiallyequal to the tension in the filament 80. As the tension of the filament80 progressively increases as the user continues to pull the tensionerassembly 200 away from the recipient (via pulling on the frame 1120 orelement 162), the spring 1220 continues to be compressed, thus resultingin a gradual increase in the tension of the filament 80 as the tensionerassembly is continued to be pulled away from the recipient. This ascompared to the relatively sudden increase in tension that would existif the hub assembly 1140 were instead rigidly fixed to the tensionerassembly 1110 and/or the spring 1220 were not present (or if structure170 were instead rigidly fixed to the tensioner assembly 140 and/or thespring 150 were not present. In this regard, the spring 1220 I spring150 provides a dampening or cushioning effect with respect to the forceapplied to the inner wall of the blood vessel or other body passagewaywhich reacts against the toggle 30 at the time that the filament 80 isfully unwound from the spool. Thus, there should be no sudden increasein the force/pressure on the wall at the location of the toggle 30.Instead, there should be a gradual increase in the force/pressure on thewall at the location of the toggle 30. In an exemplary embodiment, thehub assembly 1140 may travel about eight (8) millimeters upon theapplication of about two (2) pounds of tension force in the filament 80before bottoming out (i.e., the hub assembly 1140 cannot move furtherdownward/frame 1120 cannot move further to the upward with respect toFIG. 15). Thus, an embodiment provides a mechanically induced increasingtension force applied to the filament that increases with increasingdistance of the tensioner assembly away from the puncture at a rate ofless than about 1.5 pounds per 4 mm of increased distance of thedeployment instrument away from the puncture. Accordingly, in anexemplary embodiment, pulling the tensioner assembly away from thepuncture while the filament is connected thereto results in an initialcontact of the anchor to the wall of the body passageway followed by agradual increase in pressure applied to the wall by the anchor whiletension in the filament is less than about two (2) pounds. Thus, via amechanical device of the deployment instrument 200, a sudden increase inpressure applied to the wall of a body passageway by the toggle 30 isavoided.

FIG. 18 depicts spring 1120 fully compressed upon the application of two(2) pounds of tension force in the filament 80 by the user whilefilament 80 is connected to toggle 30 (which, as noted above, is lodgedin the artery). By bottoming out the hub assembly 1140, and not pullingon the tensioner assembly too much more after that, the user can ensurethat he or she has applied about two (2) pounds of tension force on thefilament 80, and not too much more. This ensures that sufficient tensionhas been applied to the filament to properly deploy the closure device85, and not too much more. Also, the spring 1220/spring 150 at leastpartially reduces what otherwise might be a spike in the force appliedto the wall of the artery upon the filament 80 becoming completelyunwound from the spool and becoming unslackened due to movement of thetensioner assembly away from the recipient.

In an exemplary embodiment, the user feels/senses the gradual increasein tension as the spring 1220 I spring 150 is compressed (as compared tothe relatively static tension resulting from friction block 1210/element174), and thus is provided an indication that the tensioner assemblywill soon reach the mechanical limits of its withdrawal away from therecipient, after which any further withdrawal will be due to the plasticand/or elastic nature of the filament and the recipient. In someembodiments, the spring 1220 is a linearly compressible spring, and thusthe gradual increase in tension as the spring 1220 is compressed islinear. Non-linear compressible springs may also be used, in which casethe gradual progressive increase in tension is not linear. In anexemplary scenario of use, the user continues pulling the tensionerassembly away from the recipient until the spring 1220 I spring 150bottoms out, and then halts further movement of the tensioner assemblyaway from the recipient. Alternatively, the user can continue to pullthe tensioner assembly away from the recipient, thereby furtherincreasing the tension in the filament 80. Even with respect to thislatter scenario, the indication afforded to the user by the spring 1220I spring 150 provides the user with an opportunity to adjust thedeployment procedure to avoid injury to the recipient and/or damage tothe closure device, etc.

It is noted that as the tensioner assembly 100 is pulled away from therecipient, and by the time that the spring 1220 has bottomed out, thepulley arrangement of the filament 80 connecting toggle 30 and the plug50 causes the plug 50 to be moved into engagement with the exterior ofthe artery wall contiguous with the puncture. The tension in thefilament 80 resulting from pulling the tensioner assembly away from therecipient causes the filament 80 to somewhat deform the plug, i.e.,cause it to deform radially outward and, in some embodiments, twist.Because the spring 1220 I spring 150 permits the tension on filament 80to be controlled I ensures that sufficient tensioning and not too muchtensioning is applied to the filament during deployment of the closuredevice 20, the user is provided with some reassurance that the properamount of tensioning has been applied to the filament 80 to deform theplug and properly deploy the closure device 20.

It is noted that in an exemplary embodiment, plug 50 can be withdrawnfrom tube 120 without contacting the sheath 10 and/or at least withoutcontacting the interior of the sheath 10. This may, in some embodiments,eliminate the possibility that the plug 30 might become stuck in thesheath 10—during the deployment procedure as it expands once leaving thetube 120.

It is noted that an exemplary embodiment includes an indicator thatprovides an indication to the user that the hub assembly 1140 hasbottomed out within the frame 1120 (or corresponding structure). In anexemplary embodiment, the indicator corresponds to, at leastconceptually and/or functionally, to the indicator taught in the '653application, the contents of which pertaining to the indicator beingincorporated herein by reference in their entirety for use in anembodiment.

Accordingly, in an exemplary embodiment, referring to the flowchart ofFIG. 19, there is a method of sealing a percutaneous puncture in a wallof a body passageway, comprising, at step 1, providing a deploymentinstrument 100 including a tensioner assembly 1110/140 and carrying aclosure device 80, the closure device 80 including a toggle, a plug 50and a contiguous elongate filament 80 configured to draw the plug 50towards the toggle 30 upon the application of tension to the filament 80in a direction away from the toggle 30. At step 2, the distal end of thedeployment instrument 100 is positioned through the puncture into thebody passageway such that the toggle 30 is located in the bodypassageway. At step 3 the deployment instrument 100 is pulled away fromthe puncture while the filament 80 is connected to the deploymentinstrument. This results in the application of a mechanically inducedincreasing tension force to the filament 80 that increases withincreasing distance of the deployment instrument 100 away from thepuncture, thereby drawing the toggle 30 and the plug 50 towards eachother and into engagement with the wall of the body passageway atrespectively opposite sides of the wall. In an exemplary embodiment, themechanically induced increasing tension force is a result of spring, asdetailed above.

FIG. 20A depicts an embodiment that utilizes two plugs 50 and 50′, eachlocated on a portion of loop 82, with a single toggle 30. An exemplaryembodiment of such a configuration provides utility in that two plugsmay better seal a relatively large puncture. In this regard, somepunctures will extend a relatively great distance about the artery wallin a direction normal to the longitudinal axis thereof. For example, thepuncture may extend over an arc that extends about 20, 25, 30, 35, 40,45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160 170and/or about 180 degrees or more and/or angles in between these inone-degree increments. A single plug may bunch at the apex of thepuncture, thus leaving portions of the large puncture exposed on eitherside of the plug. The use of two plugs covers more area, and thus cancover more of the puncture. By way of example, a single plug may cover apuncture extending over an arc of 10 or 20 degrees, whereas two plugsmay cover a puncture extending over an arc of about 25, or 30 or 35 or40 or more degrees. Along these lines, the use of two holes 31 for thefilament spread relatively far apart can space the plugs over the fullarea of the puncture.

It is noted that the washer 500 detailed above can be used to spread outthe filament 80 so as to avoid or otherwise reduce the tendency of theplug to bunch at the apex of the puncture in a manner the same as orsimilar to the manner by which the more widely spaced holes 31 preventsor otherwise reduces the bunching tendency.

FIG. 20B depicts a cross-sectional view of a closure device according tothe embodiment of FIG. 20A after delivery.

As can be seen in FIG. 20A, the exemplary embodiment utilizing two plugs50 and 50′ can include two tampers 70 and 70′ to tamp locks 60 and 60′.Use of these additional components may correspond to the teachingsdetailed above, albeit sequentially (tamping lock 60 first with tamper70, and then tamping lock 60′ with tamper 70′).

Still referring to FIG. 20A, an exemplary embodiment includes analternate embodiment of a tensioner apparatus. Specifically, FIG. 20Adepicts a tensioning apparatus 400. In an exemplary embodiment,tensioning apparatus 400 corresponds to a spring that is biased suchthat the ends 401 and 402 of the spring are separated as shown in FIG.20A. Specifically, ends 401 and 402 can be wrapped about filament 80 asconceptually shown, or otherwise may include devices at the ends thatpermits the filament 80 to slide relative therethrough while holding thefilament 80. Upon tensioning the filament 80 as detailed herein, the twoportions of filament 80 between element 81 and the toggle 30 will tendto move towards each other. The tensioning apparatus 400 will resistthis movement owing to the spring bias just mentioned. The more tensionapplied to the filament 80, the greater the tendency for these portionsof filament 80 to move towards each other, thus compressing thespring/moving the ends 401 and 402 closer together. Accordingly, a usercan view the degree of closure of the spring/movement of ends 401 and402 closer to one another, and thereby determine or otherwiseestimate/gauge how much tension is being applied. In an exemplaryembodiment, a gauge may be included with tensioning apparatus 400 thatpermits the user to read the tension on the filament 80 owing to thelocation of the ends 401 and 402 (or the arms that support the ends)relative to the gauge. In yet an alternate embodiment, a spacer elementmay be present between the ends (or arms) that functionally permits thespring to bottom out in a manner akin to that detailed above withrespect to spring 1120/150, and thus having thefunctionality/utilitarian value of that configuration.

FIG. 21 depicts a variation of the embodiment of FIG. 20A, where insteadof two separate tampers, a single tamper 75 is present that includes twolumens through which the two sides of the filament that forms loop 82extends the same embodiment with a double lumen tamper used to includethe double sutures.

In another embodiment, the occlusion balloon 600 is moved distally fromthe occlusive position to the puncture site, whereby the occlusiveballoon 600 is utilized to assist with positioning the toggle 30 and/orthe plug 50 and sealing the puncture. Such is depicted by way of exampleand not by way of limitation in FIG. 22. Exemplary actions associatedwith such a procedure can include first position toggle intra-arteriallyas detailed herein and/or variations thereof in general, and, inparticular, with respect to FIG. 6. Once the toggle 30 is positionedproximate the puncture, the occlusion balloon is deflated. Next, theocclusion balloon 600 is moved from its occlusion position to a locationcorresponding to a longitudinally proximate position of the puncture.After this, the occlusion balloon 600 is re-inflated to occludingpressure and/or another pressure that will enable the teachings detailedherein and/or variations thereof to be practiced. This can push thetoggle 30 against the interior of the artery as shown in FIG. 22. Theuser can then double check the final position of the toggle 30 (usingfluoroscopy or the like) and/or make adjustments to the tension orpositioning of the plug 50 before deflating the balloon 600. (Beforedeflating the balloon, the closure device 20 may be secured in placeaccording to the teachings detailed herein and/or variations thereof, orsuch may be done after deflating the balloon.) FIG. 22 depicts an actionof this method, where it can be seen how the balloon 600 covers thetoggle 30 and puncture site. This the action associated with FIG. 22 canallow for full compaction of the plug 50 without any risk of orotherwise significantly statistically reducing the chances ofreinsertion of the plug within the artery as compared to that whichwould exist without use of the balloon 600.

An exemplary embodiment includes the use of a double balloon catheter,where the proximal balloon serves to occlude flow, while the second, andmoveable (slideable) balloon is utilized to assist with toggle andcollagen placement as above. FIG. 23 depicts an action associated with amethod of such an embodiment, where balloon 600′ is the occludingballoon and balloon 600 is the balloon that is used to position thetoggle 30.

FIGS. 24A, 24B and 24C depict an alternate embodiment of a toggle.

Specifically, these figures depict a toggle 135 having hinged wings orflaps 136 and 137 via hinge features 136A and 137A. Hinge features maybe barrel hinges or may be areas of relative weakness that enables thewings to hingedly move (or flap). Toggle 135 has a width WI that islarger than the maximum internal diameter of the sheath 10 on a planenormal to the longitudinal axis thereof. In this regard, wings 136 and137 of the toggle 135 (e.g., portions outboard of the dashed lines seenin FIGS. 24A-24C), are located outboard of the inboard portion of thetoggle represented by main body 138. In an exemplary embodiment, theoutboard portions are flexibly connected or otherwise hingedly connectedto the rest of the toggle 135.

In an exemplary embodiment, the toggle 135 is configured to elasticallydeform at the areas of the hinges and/or thereabouts. By way of example,width WI of FIG. 24A is a first value, corresponding to any of thevalues detailed above with respect to the tip to tip distance and/orvariations thereof, and this value corresponds to the value when thetoggle 135 is in the relaxed state. Upon the application of a force tothe wings, the value of WI increases, by about 4 mm (about 2 mm for eachwing), although in alternate embodiments, the value WI increases byabout 0.5 mm, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25,3.5, 3.75, 4, 4.25, 2.4, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.25, 6.5, 6.75and/or any value in between these values and/or any ranges encompassingsome or all of these values (including ranges being bounded by the inbetween values).

This increase in value of WI, or at least a portion thereof, elasticallydeforms the toggle 135, such that it retains the new value of WI orsomething close to that or something in between, depending on theelastic properties that come into play associated with the plasticproperties.

FIG. 24D depicts a cross-sectional view of toggle 135 through sectionA-A of FIG. 24C. As can be seen, hinge features 136A and 137A arenotched sections in the top surface of the toggle 135. In an alternateembodiment, the notches are located in the bottom surface. In analternative embodiment, the notches are located both above and below. Inan exemplary embodiment, hinge feature 136A is a notch located on thetop and hinge feature 137A is a notch located on the bottom, orvisa-versa. (The holes 31 are not depicted in the cross-sectional viewof FIG. 24D.)

Any device, system and/or method that enables the folding functionsdetailed herein and/or variations thereof with respect to the wings maybe utilized in some embodiments.

In an exemplary embodiment, the toggle 135 is such that the resistanceto flexture of the toggle along lines 136A and/or 137A is substantiallyand/or effectively less than resistance to flexture of the toggle atlocations generally proximately inboard and outboard thereof. In anexemplary embodiment, the toggle 135 is such that the elastic modulus ofthe toggle along lines 136A and/or 137A is substantially and/oreffectively less than that of the toggle at locations generallyproximately inboard and outboard thereof.

As noted above, the wings may expand upon the application of sufficientforce thereto. In this regard, an exemplary embodiment of the toggle 135is utilized in conjunction with a balloon 600 in a manner similar toand/or the same as that detailed above with respect to FIG. 22. Moreparticularly, FIGS. 25A, 25B and 25C schematically illustrate a sequenceaccording to an exemplary embodiment combining the above teachings. FIG.25A depicts the toggle 135 positioned at the puncture, with the wings136 and 137 drooping downward prior to applying tension to the filamentbeyond about that which is used to hold the toggle 135 against thepuncture (e.g., prior to cinching the loop 80, etc.) Balloon 600 isdepicted in a deflated or semi-deflated state and is locatedlongitudinally proximally to the puncture (and toggle 135).

FIG. 25B depicts inflation of the balloon 600. As the balloon expandsoutward, wings 136 and 137 are forced outward towards the wall of theartery 1026. FIG. 25C depicts the balloon 600 inflated to at least aboutits maximum inflation dimensions. As can be seen, the wings 136 and 137are trapped against the wall of the artery between the wall and theballoon 600. At this time, additional tension is applied to the filament80 to move the plug 50 (not shown) towards the toggle 135, etc. Moreparticularly, FIG. 25C depicts how balloon 600 (single or doubleembodiment) may be used to orient the wings 136 and 137 of the toggle135 to assist with internal closure.

Exemplary embodiments of FIGS. 24A-D and/or 25A-C can be used tosubstantially and/or effectively statistically reduce the chances of thetoggle 135 dislodging and/or passing through the puncture and into thetract relative to the other embodiments detailed herein and/orvariations thereof. This statistical phenomenon may be, for example,because the additional area of the toggle 135 owing to the wings becausethe wings can be folded for insertion into the sheath 10. This ascompared to a toggle without folding wings, where the maximum size ofthe toggle is limited by the internal diameter of the sheath 10.

Exemplary embodiments of FIGS. 24A-D and/or 25A-C can be used inapplications where the puncture extends over a larger arcuate distanceas compared to toggles having smaller widths. For example, the puncturemay extend over an arc that extends about 20, 25, 30, 35, 40, 45, 50,55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160 170 and/orabout 180 degrees or more and/or angles in between these in one degreeincrements. The embodiments of FIGS. 24A-C and/or 25A-C cansubstantially and/or effectively statistically reduce the chances of thetoggle 135 dislodging and/or passing through such punctures puncture andinto the tract relative to the other embodiments detailed herein and/orvariations thereof.

FIGS. 26A and 26B depict another embodiment, where the filament isutilized to apply the above-mentioned force to the wings to expand thewings. In this regard, FIG. 26B is a cross-sectional view of section AAof the toggle 300 depicted in FIG. 26A. In this embodiment, the holes311 of the toggle 300 for the filament 80 are angled relative to thelateral axis 301 or positioned so as to aid in the support of thewidened portion, or ‘wings’. In an exemplary embodiment, this can aid inopening the toggle 300, which has hinge sections 300A and 300B extendingalong the midline. In an exemplary embodiment, loop 82 extends throughholes 311 as may be seen. The angle of the holes relative to axis 301has utility in that as the loop 82 is closed due to the tensioning offilament 80, the filament 80 applies a force onto wings 302A and 302B,lifting the wings upward and against the artery. It is noted that suchutility can also be achieved without the angling of the holes 311relative to axis 301. In this regard, because the holes 311 are outboardof the hinge sections 300A and 300B, the force resulting from thetensioning of the filament 80 is applied to the wings, thus forcing thewings upward and against the artery.

In addition to radiopaque marking schemes mentioned above, someembodiments detailed herein and/or variations thereof may includeadditional markers to ensure or otherwise substantially and/oreffectively statistically improve the chances of utilitarianly deployingthe toggles. Radiopaque markings on the tubes can aid in enabling theuser to estimate the amount of delivery tube and/or release tube thathas been pushed into the vessel. This can help the user avoidnonutilitarian advancement of the toggle into the vessel (e.g., too muchadvancement), thereby obviating any adverse situations during deploymentsuch as catching of the toggle on the inner wall downstream. Thedelivery tube and/or the release tube may have radiopaque strips orrings at fixed distances. It may also have rings with increasingthicknesses. The gradient may be designed in proportion to a qualitativeassessment of distance advanced. The tube(s) may also have dots in placeof rings to differentiate between the radiopaque sheath tip and thedelivery tube.

In a similar vein, an exemplary embodiment includes a toggle or otherdegradable intraluminal sealing member that includes a radiopaquemarker. In an exemplary embodiment, one or more or all of theembodiments of toggles detailed herein and/or variations thereof mayinclude therein a relatively thin stainless steel radiopaque marker(thickness of 0.005″-0.010″). In some exemplary embodiments, the markermay have hollow features. FIGS. 27A-D depict such an exemplaryembodiment of a marker 2700, having hollow holes 2701 in arms 2702extending from a core 2703. Embedded in or otherwise attached to atoggle, the hollow features can be utilized to indicate toggleorientation during deployment. By way of example, depending on theorientation of the toggle relative to a viewing perspective, the holeswill appear anywhere from circular to highly elliptical. Moreparticularly, under fluoroscopic guidance, the holes appear circular at0° relative to the viewing perspective (FIG. 27A), elliptical at 15°relative to the viewing perspective (FIG. 27B), more elliptical at 30°relative to the viewing perspective (FIG. 27C) and highly-ellipticaland/or closed off completely (i.e., one cannot see through the hole asthe wall of the hole blocks the view) at 45° (FIG. 27D). Accordingly,there is a method of fluoroscopically confirming the orientation of thetoggle relative to a viewing perspective based on how the holes lookrelative to a viewing perspective prior to initiating any of the actionsdetailed herein and/or variations thereof associated with deployment ofthe toggle.

More particularly, in an exemplary embodiment, during deployment of thetoggle, the holes may appear closed (or highly elliptical) as the toggleis released from the delivery instrument and hangs in the intraluminalspace. As the toggle is brought closer to the vessel wall as detailedherein, the varying degrees of circularity of the holes relative to aviewing perspective via fluoroscopy can provide the user with a visualconfirmation of accurate positioning and/or utilitarian positioning ofthe toggle.

In an exemplary embodiment, the marker can also be used as a reinforcingelement that reinforces the toggle and improves resistance to thetensioning of the filament as detailed above. This can have utilitarianvalue in that it can substantially and/or effectively statisticallyincrease the likelihood that the toggle stays in contact with the innerwall of the vessel throughout the period of resorption. This as comparedto that which would be the case in a similarly situated toggle withoutthe marker. In an exemplary embodiment, the “marker” need never be usedas a marker, but instead simply only as a reinforcing device.

As noted above, an exemplary embodiment includes a guide wire 20 thatpasses through holes in the plug 50. FIGS. 28, 29 and 30 depictexemplary embodiments, of such a configuration. In a further embodiment,there is an extra luminal sealing component 550, as depicted in FIG. 30,that is in the form of a stainless steel (or any of a variety ofimplantable or absorbable materials) plate or bar about 0.5″ long orless and about 0.010″ thick or less placed between the hemostatic pad 50and the lock 60. The plate 550 can have utilitarian value in that it canincrease or otherwise result in utilitarian distribution of compressionforces on the plug 50 more evenly in order to achieve statisticallyand/or effective reliable hemostasis.

FIG. 31 depicts the exchange system 13 intended to improve the deliveryof the large bore closure device described herein; namely an accessoryintroducer 15 and an accessory sheath 10. The accessory introducer 15and accessory sheath 10 may be assembled together as shown, where theaccessory introducer shaft 17 fits inside accessory sheath shaft 12 andaccessory introducer hub 15 engages or snaps to accessory sheath hub 11to keep the two components locked together. Squeezing accessoryintroducer hub 16 allows for removal of the accessory introducer 15 fromaccessory sheath 10 as needed. The placement of the exchange system 13is accomplished following a method termed ‘sheath exchange,’ whereby aprocedure sheath that is in place in the vessel during theinterventional procedure is removed from the patient and a new,different sheath is inserted over the procedural guidewire. As istypical on any sheath insertion, an introducer or dilator is requiredwithin the sheath to permit easy sheath insertion into the vessel overthe procedure wire. Thus, once the interventional procedure iscompleted, the procedure wire is held in place, and the proceduralsheath is removed from the vessel and the slid proximally off theprocedure wire. Manual compression is applied to the vessel puncturesite to control bleeding while the assembled exchange system 13 isadvanced over the procedural guidewire into the existing vesselpuncture. Once the exchange system 13 is in place within the vessel, theaccessory introducer 15 and procedural guidewire are removed from theaccessory sheath 10. The accessory sheath 10 remains in place within thevessel, and as will be described below, is used to facilitate properplacement of the closure device delivery system within the patient.

The accessory sheath 10 also contains a sheath hub 11 that houses ahemostasis valve (not shown). This valve is common in vascular sheathsand is required to avoid blood loss while providing the ability toinsert devices and guidewires into sheaths with minimal blood loss. Inthe case of the accessory sheath 10, the hemostasis valve within the hubis intended to prohibit blood loss from the accessory sheath until andduring the time the closure device delivery system can be inserted. FIG.32 depicts an embodiment of the closure device delivery system 100′containing the closure device (not shown) and a guidewire 20, which isalso inside the closure device delivery system 100′. As has beenpreviously described previously herein, guidewire 20 is similar in formand function to procedural guidewires, but in combination with theclosure delivery system, serves to facilitate placement of the closuredevice elements around the vessel puncture during deployment of theclosure device. To begin the deployment procedure, the guidewire 20 ofthe closure device delivery system 100′ is inserted into and past thehemostasis valve in the sheath hub 11, until the bypass tube 45 of thedelivery system 100′ enters the accessory sheath hub 11 and is pushedinside the hub to open the hemostasis valve. The delivery system shaft40 is then slid inside the stationary bypass tube 45, past the openedhemostasis valve, until the delivery system handle 110′ abuts the sheathhub 11. On full insertion, the delivery system handle 110′ locks to theaccessory sheath hub 11, indicating to the user that the delivery system100′ is positioned correctly within the accessory sheath 10.

Delivery system shaft 40 is designed to be longer than accessory sheathshaft 12, thus the delivery system shaft 40 extends distally into thevessel beyond the tip of the accessory sheath shaft 12. This isnecessary to permit release and deployment of the closure elements insubsequent steps deployment steps previously describe herein.

The contents of the closure device delivery system 100′ in a preferredembodiment are shown in FIG. 33, and include the guidewire 20, thetoggle 30, the collagen pad 50, a slideable knot 81, a lock 60, thetamper tube 71, the connecting suture 80, the tensioning cartridge 160,and a tensioning o-ring 170. These components are housed within thedelivery system and have been described previously. Of particularimportance is the inclusion of the guidewire 20 within the closuredevice delivery system 100′, central to all components, such that theuser of the delivery system is not required to ‘thread’ the guidewirethrough the various internal components, but rather it is assembledbeforehand. In this manner the closure device delivery system 100′ isassembled as shown, containing the guidewire 20. During use theguidewire 20 and closure device delivery system are inserted together ina fixed-wire fashion into the accessory sheath 10, whereby the guidewire20 is advanced by the action of advancing the closure device deliverysystem 100′.

In a previous description, the tensioning o-ring 170 was described toencircle the tensioning cartridge and provide drag against the internalsurface of the delivery system shaft 40. As shown in FIGS. 33 and 34,the o-ring 170 alternatively can be tethered to the cartridge and pulledalong behind the cartridge during deployment, achieving similar dragwhen the outside diameter of o-ring 170 is larger than the insidediameter of delivery system shaft 40. This arrangement provides anexcellent system for deployment tension or drag, as the o-ring elongatesunder tension during deployment, which acts to regulate the drag forces,making this design arrangement less dependent upon tight dimensionalspecifications.

In some instances, it would also be preferable to advance the closuredevice system over the procedural guidewire, rather than utilizingguidewire 20 as part of the assembly. An alternate embodiment is shownin FIG. 34 that utilizes a tube 190 that defines a guidewire lumen andincludes a hub 180 as a substitute for guidewire 20 during themanufacturing assembly process. In this embodiment, a closure devicesystem 100′ can include a toggle 30 configured to engage an interiorsurface of the vessel wall, a plug or collagen pad 50 configured toengage an exterior surface of the vessel wall, and a suture 80 thatextends through the plug 50 and through the toggle 70 along at least afirst direction so as to couple the toggle 70 to the plug 50 such thatthe plug 50 is proximal to the toggle 70. The tube 190 extends orotherwise passes through some or all of the closure device elements. Asshown, the tube 190 extends through the plug 50 and through the toggle70 along the first direction such that a distal end of the tube 190 isdisposed distally to the toggle 70. The guidewire lumen of the tube 190extends therethrough along the first direction and is configured toreceive a guidewire such that the plug 50, toggle 70, and tube 190 areslidable along the guidewire toward the vessel wall.

To facilitate guidewire insertion into the guidewire lumen of the tube190, the tube 190 extends beyond the toggle 30 so that the user canaccess the distal end of the tube 190 without difficulty. The extensionof the tube 190 can be approximately lcm or as long as 2-3 cm, or longerfrom the toggle 70.

With continued reference to FIG. 34, the system 100′ can further includea tamper 71 that is proximal to the plug 50 and a lock 60 coupled to thesuture 80 between the plug 50 and tamper 71. The tamper 71 is configuredto contact and move the lock 60 against the plug 50 to thereby compressthe plug against the vessel wall such that the compressed plug 50 isheld against the vessel wall by the toggle 70 and the lock 60.

The tamper 71 defines a suture lumen that extends therethrough along thefirst direction and tamper guidewire lumen that extends therethroughalong the first direction. As shown in FIG. 34, the tube 190 extendsthrough the tamper guidewire lumen and the suture 80 extends through thesuture lumen such that the plug 50, toggle 70, tube 190, and tamper 71are slidable along the guidewire toward the vessel wall. In particular,the suture 80 extends from the suture lumen of the tamper 71, throughthe plug 50 and through the toggle 70 along the first direction so as todefine a first portion of suture. The suture 80 then loops back throughthe toggle 70 and through the plug 50 along a second direction that isopposite the first direction so as to define a second portion of suture80. The second portion of suture terminates in a knot 81 between thelock 60 and the plug 50 such that the suture 80 forms a loop that beginsand ends at the knot 81. The tube 190 preferably extends through theplug 50 between the first and second portions of the suture 80. Itshould be appreciated, however, that the tube 190 can extend throughother portions of the plug 50 relative to the suture 80, as desired.

As shown in FIG. 34, the hub 180 is attached within the deploymentdevice handle 110′, and the tube 190 passes through a delivery tube 40of the deployment device. The delivery tube is configured to hold theclosure device including the plug 50, toggle 70, and tamper 71 when theclosure device is in a pre-deployment state. Also within the deliverytube 40 is a tensioning cartridge 160 that receives the suture 80 suchthat when the deployment device is pulled proximally the tensioningcartridge 160 increases the tension in the suture and subsequentlyprovides a feedback indicating that the suture is fully tensioned. Thetube 190 extends through the tube 40, through the cartridge 160, andalso through the portions of the closure device while the device is inthe pre-deployment state. Thus, a tube is contained within some or allthe closure device elements and subsequently permits insertion of aguidewire and easy advancement of the closure device delivery system100′ over a procedural guidewire rather than over the guidewire 20 asshown in FIG. 33.

In operation a guidewire is inserted into the body passageway such thatthe guidewire extends from outside the body passageway, through thepuncture, and into the body passageway. The guidewire is then insertedinto the guidewire lumen of the tube 190 and the closure system 100′ ismoved along the guidewire such that the toggle 70 enters the bodypassageway through the puncture. The delivery device is then pulledproximally to thereby deploy the plug 50 and tamper 71. Further pullingwill also pull the tube 190 proximally so as to remove the tube 190 fromthe closure device (e.g. the toggle 70, the plug 50, and the tamper 71).

Embodiments disclosed herein and variations thereof include variousinterventional cardiology procedures which utilize large access sheathsto accommodate large devices. Non-exhaustive examples may includemethods that include steps of balloon aortic valvuloplasty (BAV) andpercutaneous aortic valve replacement (PAVR), both of which are utilizedwith sheaths ranging from 12-24 F. Closure of access sites involvingsheaths this large are accomplished with the closure devices anddeployment instruments disclosed herein and variations thereof, as wellas methods for closing such access sites disclosed herein (whichincludes those disclosed in the above referenced applications, scaledfor such closure) instead of and/or in addition to surgical closureprocedures and/or the use of multiple traditional vascular closuredevices. In an exemplary embodiment, the devices and methods disclosedherein and variations thereof reduce by 50%, 75%, 90%, 95%, and/or 99%or more the failure rates associated with closure of access sites of thejust-mentioned procedures (i) such as those disclosed by, for example,Herrmann et al, discusses the successful use of multiple 8 F Angio-Sealdevices (St Jude Medical, Minnetonka, Minn.) to close the arterialaccess site from BAV procedures, combating historical vascularcomplication rates from various studies ranging from 11-23%, (ii) and/orsuch as those disclosed by the Ramy et al. report on the use of threePerclose devices utilized for the closure of PAVR arterial access sites,suggesting deployment of the devices at 60 degree offsets to completelyclose the arteriotomy around the periphery.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. It will be apparent to persons skilledin the relevant art that various changes in form and detail can be madetherein without departing from the spirit and scope of the invention.Thus, the breadth and scope of the present invention should not belimited by any of the above-described exemplary embodiments but shouldbe defined only in accordance with any future claims and theirequivalents.

What is claimed:
 1. A vascular closure system for sealing a puncture ina vessel wall, comprising: a closure device configured to seal thepuncture in the vessel wall, the closure device having a first opening,a second opening that extends therethrough, and a suture that extends atleast through the first opening of the closure device so that theclosure device is slidable along the suture; and an elongated tubehaving a proximal end, a distal end spaced from proximal end of theelongated tube in a distal direction, and a guide lumen that extendsfrom the distal end toward the proximal end, wherein the elongated tubeextends through the second opening such that the distal end of theelongated tube is spaced apart from the closure device in the distaldirection, wherein the guide lumen is configured to receive a guidewiresuch that the closure device and the elongated tube are slidable alongthe guidewire toward the vessel wall.
 2. The system of claim 1, furthercomprising a tamper having a first lumen that receives the suture and asecond lumen that receives the elongated tube.
 3. The system of claim 1,wherein the closure device includes an anchor, the anchor having a lowersurface, a wall engaging surface spaced from the lower surface, and thesecond opening extends from the wall engaging surface to the lowersurface of the anchor.
 4. The system of claim 3, wherein the elongatedtube is movable relative to the anchor so that the distal end of theelongated tube is removable from the second opening of the anchor in aproximal direction that is opposite the distal direction.
 5. The systemof claim 1, wherein the closure device includes a plug having a firstplug opening and a second plug opening separate from the first plugopening, wherein the suture extends through the first plug opening andthe elongated tube extends through the second plug opening.
 6. Thesystem of claim 1, further comprising: a delivery tube; and a releasetube that restrains at least a portion of the closure device, wherein atleast one of the delivery tube and the release tube are moveablerelative to the other of the delivery tube and the release tube torelease the at least a portion of the closure device.
 7. The system ofclaim 6, wherein the elongated tube is coupled to the delivery tube,such that the delivery tube and elongated tube are movable together. 8.The system of claim 1, further comprising: a sheath having a proximalend, a distal end, and a channel that extends therethrough from distalend toward the proximal end; and a deployment instrument configured tobe inserted into the channel of sheath, the deployment instrument havinga proximal end and a distal end, wherein the closure device is carriedby the distal end of the deployment instrument.
 9. A system for sealinga percutaneous puncture in a vessel wall, the system comprising: ananchor having a thickness, a first opening, and a second openingseparate from the first opening; a suture that extends through the firstopening of the anchor; and an elongated tube having a proximal end, adistal end opposite the proximal end in a distal direction, and a tubelumen that extends from the distal of the elongated tube toward theproximal end of the elongated tube, wherein the elongated tube extendsthrough the second opening of the anchor along its thickness so that thedistal end of the elongated tube is spaced from the anchor in the distaldirection.
 10. The system of claim 9, wherein the anchor has a firstend, a second end, a length that extends from the first end to thesecond end, a lower surface, a wall engaging surface opposite the lowersurface, a thickness that extends from the wall engaging surface to thelower surface, and the first and second opening extend from the wallengaging surface toward the lower surface, wherein the thickness isperpendicular to the length.
 11. The system of claim 9, furthercomprising a plug having a first plug opening and a second plug openingseparate from the first plug opening, wherein the suture extends throughthe first plug opening and the elongated tube extends through the secondplug opening.
 12. The system of claim 9, further comprising a tamperhaving a first lumen that extends therethrough and a second lumen thatextends therethrough, wherein the suture extends through the first lumenand the elongated tube extends through the second lumen.
 13. The systemof claim 12, wherein the tube lumen is configured to receive a guidewiretherethrough such that the anchor and the elongated tube are slidablealong the guidewire.
 14. The system of claim 9, further comprising: asheath having a proximal end, a distal end, and a channel that extendstherethrough from distal end toward the proximal end; a deploymentinstrument that is insertable into the channel of the sheath, thedeployment instrument having a proximal end and a distal end, whereinthe anchor is carried by the distal end of the deployment instrument.15. A vascular closure system for sealing a puncture in a vessel wall,comprising: a closure device configured to seal the puncture in thevessel wall, the closure device having a first opening and a secondopening that extends therethrough; a suture that extends at leastthrough the first opening of the closure device; a tension cartridgecoupled to the suture and configured to control application of tensionto the suture; and an elongated tube having a proximal end, a distal endspaced from proximal end of the elongated tube in a distal direction,and a guide lumen that extends from the distal end toward the proximalend, wherein the elongated tube extends through the tension cartridgeand the second opening of the closure device such that the distal end ofthe elongated tube is spaced apart from the closure device in the distaldirection, wherein the guide lumen is configured to receive a guidewiresuch that the closure device and the elongated tube are slidable alongthe guidewire.
 16. The system of claim 15, further comprising a tamperhaving a first lumen that receives the suture and a second lumen thatreceives the elongated tube.
 17. The system of claim 15, wherein theguide lumen is configured to receive a guidewire therethrough such thatthe closure device and the elongated tube are slidable along theguidewire.
 18. The system of claim 15, further comprising: a sheathhaving a proximal end, a distal end, and a channel that extendstherethrough from distal end toward the proximal end; and a deploymentinstrument that is insertable into the channel of the sheath, thedeployment instrument having a proximal end and a distal end, whereinthe closure device is carried by the distal end of the deploymentinstrument.
 19. The system of claim 18, further comprising: a deliverytube; and a release tube that restrains at least a portion of theclosure device, wherein at least one of the delivery tube and therelease tube are moveable relative to the other of the delivery tube andthe release tube to release the at least a portion of the closuredevice.
 20. The system of claim 19, wherein the elongated tube iscoupled to the delivery tube, such that the delivery tube and elongatedtube are movable together.